{"title":"Registration","description":null,"products":[{"product_id":"us-fda-premarket-submission-regulatory-strategy","title":"U.S. FDA Premarket Submission \u0026 Regulatory Strategy","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} 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.eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-4:checked ~ .eximio-flow-panels .eximio-flow-panel-4{display:block} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-5:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-premarket-submission-regulatory-strategy-5\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-premarket-submission-regulatory-strategy-5:checked ~ .eximio-flow-panels .eximio-flow-panel-5{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} 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solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO provides regulatory support for medical-device manufacturers preparing to enter the U.S. market. The service covers regulatory strategy, FDA interaction planning, technical-document preparation, submission coordination and response support across the main premarket routes represented in the source material.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-1\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-2\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-3\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-4\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-5\" name=\"eximio-v6-flow-us-fda-premarket-submission-regulatory-strategy\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-1\"\u003ePre-Submission (Q-Sub)\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-2\"\u003e513(g) Request\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-3\"\u003e510(k) Premarket Notification\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-4\"\u003eDe Novo Request\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-premarket-submission-regulatory-strategy-5\"\u003ePMA (Modular)\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003ePre-Submission (Q-Sub)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA feedback target\u003c\/span\u003e\u003cstrong\u003e~70 calendar days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.45\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:14.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:14.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:14.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:14.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:14.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:38.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:38.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:24.00%;height:26.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:38.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:24.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:38.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:50.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:68.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:6%;--nw:22%\"\u003eQ-Sub \/ Pre-Submission\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:10%;--y:24%;--nw:16%\"\u003ePre-Submission Procedure\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:30%;--y:24%;--nw:16%\"\u003eQuestions \/ FDA Feedback\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:24%;--nw:16%\"\u003eStudy Risk Definition\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:24%;--nw:16%\"\u003eInformation Meeting\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:90%;--y:24%;--nw:16%\"\u003eCommunication \/ Follow-up\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:50%;--nw:20%\"\u003eProduct Testing \/ Evidence\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:68%;--nw:21%\"\u003eCompile Submission Package\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:88%;--nw:22%\"\u003eFDA Feedback \/ Recommendations\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003e513(g) Request\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eExpected FDA response window\u003c\/span\u003e\u003cstrong\u003e~60 days\u003c\/strong\u003e\u003csmall\u003eOfficial guidance + source timing\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.98\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:6.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:20.00%;top:14.00%;width:44.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:14.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:6.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:23.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:44.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:20.00%;top:65.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:24.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:46.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:67.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:64%;--y:6%;--nw:22%\"\u003eFDA 513(g) Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:23%;--nw:19%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:44%;--nw:19%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:20%;--y:65%;--nw:19%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:20%;--y:88%;--nw:23%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:24%;--nw:20%\"\u003eProvide Device Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:46%;--nw:20%\"\u003eSubmit 513(g) Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:67%;--nw:22%\"\u003eFDA Review \/ Supplemental Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:64%;--y:89%;--nw:20%\"\u003eFDA Written Response\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:38%;top:13%\"\u003eEnterprise registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003e510(k) Premarket Notification\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA review goal\u003c\/span\u003e\u003cstrong\u003e90 FDA days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.76\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:11.00%;width:48.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:11.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:62.00%;top:12.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:12.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:62.00%;top:5.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:15.00%;width:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:15.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:18.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:22.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:22.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:18.00%;height:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:42.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:65.00%;height:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:39.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:52.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:65.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:77.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:87.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:94.00%;height:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:94.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:92.00%;height:2.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:62%;--y:5%;--nw:22%\"\u003e510(k) Premarket Notification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:18%;--nw:18%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:42%;--nw:18%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:65%;--nw:18%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:14%;--y:92%;--nw:24%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:18%;--nw:19%\"\u003eApplicant \/ Company Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:25%;--nw:22%\"\u003ePredicate \/ Substantial Equivalence Strategy\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:39%;--nw:21%\"\u003eApplicable Standards \u0026amp; Test Items\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:52%;--nw:18%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:65%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:77%;--nw:20%\"\u003eFDA First Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:87%;--nw:20%\"\u003eFDA Second Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:60%;--y:96%;--nw:20%\"\u003eFormal 510(k) \/ K Number\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:36%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eDe Novo Request\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA review goal\u003c\/span\u003e\u003cstrong\u003e150 review days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.7\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:14.00%;top:12.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:5.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:20.00%;height:25.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:45.00%;height:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:14.00%;top:69.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:18.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:31.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:43.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:55.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:67.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:36.00%;top:78.00%;width:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:60.00%;top:78.00%;width:25.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:78.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:60%;--y:5%;--nw:21%\"\u003eFDA De Novo Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:20%;--nw:18%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:45%;--nw:18%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:14%;--y:69%;--nw:18%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:14%;--y:92%;--nw:24%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:18%;--nw:20%\"\u003eOptional Pre-Submission\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:31%;--nw:18%\"\u003eFDA Feedback\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:43%;--nw:18%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:55%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:67%;--nw:20%\"\u003eSubmit De Novo Request\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:60%;--y:78%;--nw:22%\"\u003eFDA Classification \/ Pathway Decision\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:36%;--y:78%;--nw:18%\"\u003eAlternative: PMA Pathway\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:85%;--y:78%;--nw:18%\"\u003eAlternative: 510(k) Pathway\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:89%;--nw:22%\"\u003eFDA Substantive Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:60%;--y:98%;--nw:19%\"\u003eDe Novo Granted\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:35%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003ePMA (Modular)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eFDA PMA review goal\u003c\/span\u003e\u003cstrong\u003e180 FDA days\u003c\/strong\u003e\u003csmall\u003eOfficial authority target\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.35\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:55.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:9.00%;top:12.00%;width:46.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:32.00%;top:12.00%;width:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:55.00%;top:5.00%;height:7.50%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:54.00%;top:12.50%;width:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:12.50%;height:7.50%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:55.00%;top:12.00%;width:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:78.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:78.00%;top:20.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:78.00%;top:26.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:26.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:20.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:20.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:40.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:62.00%;height:30.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:21.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:38.00%;width:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27.00%;top:38.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:54.00%;top:33.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:42.00%;width:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27.00%;top:42.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:90.00%;top:32.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:42.00%;width:63.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:39.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:51.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:63.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:75.00%;top:52.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:87.00%;top:52.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:63.00%;top:61.00%;width:24.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:61.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:68.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:81.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:93.00%;height:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:9.00%;top:93.00%;width:54.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:9.00%;top:92.00%;height:1.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:55%;--y:5%;--nw:20%\"\u003ePMA Registration (Modular)\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:20%;--nw:16%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:40%;--nw:16%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:9%;--y:62%;--nw:16%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:9%;--y:92%;--nw:22%\"\u003eEstablishment Registration \u0026amp; Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:32%;--y:21%;--nw:18%\"\u003eQMS \/ QSR Readiness\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:54%;--y:20%;--nw:17%\"\u003ePMA Shell\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:54%;--y:33%;--nw:18%\"\u003eFDA Alignment \/ Confirmation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:78%;--y:20%;--nw:16%\"\u003eProduct Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:90%;--y:32%;--nw:16%\"\u003eClinical Testing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:27%;--y:52%;--nw:13%\"\u003eModule 1\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:39%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:51%;--y:52%;--nw:13%\"\u003eModule 2\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:75%;--y:52%;--nw:13%\"\u003eModule 3\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:87%;--y:52%;--nw:13%\"\u003eFDA Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:68%;--nw:16%\"\u003eFinal Module\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:81%;--nw:20%\"\u003eFDA Final Review \/ Supplement\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:63%;--y:94%;--nw:18%\"\u003ePMA Approval\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:27%;top:10%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-807\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 807\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003ePremarket notification (510(k)) and related registration\/listing provisions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-860\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 860\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eMedical device classification procedures, including De Novo classification.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-814\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 814\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003ePremarket Approval (PMA) requirements and procedures.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/uscode.house.gov\/view.xhtml?req=granuleid:USC-prelim-title21-section360c\u0026amp;num=0\u0026amp;edition=prelim\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eStatute\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFD\u0026amp;C Act §513 \/ 21 U.S.C. §360c\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eDevice classification framework and statutory basis for §513(g) requests.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/requests-feedback-and-meetings-medical-device-submissions-q-submission-program\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA Q-Submission Program — May 2025\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent FDA guidance for Pre-Submissions, feedback and meetings.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA §513(g) Requests — August 2024\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent FDA procedure for §513(g) classification \/ requirements inquiries.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eFDA medical device listing, UDI support, U.S. agent coordination and post-submission regulatory support can be arranged as related services.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Pre-Submission (Q-Sub)","offer_id":47472020095132,"sku":"REG-FDA-PRESUB","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"513(g) Request","offer_id":47472020127900,"sku":"REG-FDA-513G","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"510(k) Premarket Notification","offer_id":47472020160668,"sku":"REG-FDA-510K","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"De Novo Request","offer_id":47472020193436,"sku":"REG-FDA-DENOVO","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"PMA (Modular)","offer_id":47472020226204,"sku":"REG-FDA-PMA-MOD","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"us-fda-establishment-registration-device-listing-service","title":"U.S. FDA Establishment Registration \u0026 Device Listing Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-us-fda-establishment-registration-device-listing-service-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-establishment-registration-device-listing-service-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-establishment-registration-device-listing-service-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-us-fda-establishment-registration-device-listing-service-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-us-fda-establishment-registration-device-listing-service-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-us-fda-establishment-registration-device-listing-service-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eThis service is intended for manufacturers that need support with U.S. FDA establishment registration and device listing. Standard device listing and 510(k)-exempt routes share the same market-entry operations, so they are more useful as variants of one product than as separate pages.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-establishment-registration-device-listing-service-1\" name=\"eximio-v6-flow-us-fda-establishment-registration-device-listing-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-establishment-registration-device-listing-service-2\" name=\"eximio-v6-flow-us-fda-establishment-registration-device-listing-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-establishment-registration-device-listing-service-1\"\u003eStandard Device Listing\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-establishment-registration-device-listing-service-2\"\u003e510(k) Exempt \/ Listing Route\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eStandard Device Listing\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative project timeline\u003c\/span\u003e\u003cstrong\u003e70–90 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:1.0\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:16.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:16.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:16.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:16.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:27.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:27.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:30.00%;top:49.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:30.00%;top:60.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:60.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:49.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:60.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:70.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:6%;--nw:21%\"\u003eFDA Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:30%;--y:27%;--nw:20%\"\u003eProduct Classification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:30%;--y:49%;--nw:21%\"\u003eEstablishment \/ Device Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:27%;--nw:19%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:49%;--nw:21%\"\u003eEstablishment Account Confirmation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:70%;--nw:20%\"\u003eComplete Device Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:90%;--nw:19%\"\u003eDevice Listing Number\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003e510(k) Exempt \/ Listing Route\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative project timeline\u003c\/span\u003e\u003cstrong\u003e~90 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.95\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:65.00%;top:6.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:25.00%;top:13.00%;width:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:25.00%;top:13.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:65.00%;top:6.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:25.00%;top:20.00%;height:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:25.00%;top:39.00%;height:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:25.00%;top:58.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:65.00%;top:22.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:65.00%;top:42.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:25.00%;top:76.00%;width:25.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:76.00%;height:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:65.00%;top:62.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:73.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:73.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:78.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:37.00%;top:86.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:86.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:86.00%;width:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:67.00%;top:86.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:65%;--y:6%;--nw:24%\"\u003e510(k)-Exempt Registration \/ Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:25%;--y:20%;--nw:18%\"\u003eConfirm U.S. Agent\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:25%;--y:39%;--nw:18%\"\u003eApply for D-U-N-S\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:25%;--y:58%;--nw:18%\"\u003ePay Annual Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:25%;--y:76%;--nw:20%\"\u003eEstablishment Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:65%;--y:22%;--nw:19%\"\u003eProduct Classification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:65%;--y:42%;--nw:21%\"\u003eCompany \u0026amp; Device Information\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:65%;--y:62%;--nw:18%\"\u003eDevice Listing\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:78%;--nw:23%\"\u003eFDA Registration \/ Listing Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:37%;--y:93%;--nw:22%\"\u003eEstablishment Registration Number\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:67%;--y:93%;--nw:20%\"\u003eProduct Listing Number\u003c\/div\u003e \u003cdiv class=\"eximio-map-note\" style=\"left:42%;top:12%\"\u003eEstablishment registration ~90 days\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-807\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 807\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eFDA establishment registration, device listing and premarket-notification provisions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/medical-devices\/how-study-and-market-your-device\/device-registration-and-listing\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA Device Registration and Listing\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eFDA overview of establishment registration and device-listing obligations.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/medical-devices\/device-registration-and-listing\/when-register-and-list\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA — When to Register and List\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent FDA timing and role-based registration\/listing guidance.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003e510(k), De Novo, PMA, 513(g), Pre-Submission and UDI services are available as related FDA support.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Standard Device Listing","offer_id":47472020291740,"sku":"REG-FDA-LIST","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"510(k) Exempt \/ Listing Route","offer_id":47472020324508,"sku":"REG-FDA-510K-EX","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"us-fda-udi-application-service","title":"U.S. FDA UDI Application Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO supports manufacturers preparing Unique Device Identification (UDI) information for the U.S. market. The source workflow covers identifier-system membership, device identifier creation, GUDID account setup, GMDN-code preparation and final device-data entry.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-us-fda-udi-application-service-1\" name=\"eximio-v6-flow-us-fda-udi-application-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-us-fda-udi-application-service-1\"\u003eUDI \/ GUDID Support\u003c\/label\u003e\u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e\u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eUDI \/ GUDID Support\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative project timeline\u003c\/span\u003e\u003cstrong\u003e2–4 weeks\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.82\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:26.00%;top:6.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:26.00%;top:24.00%;height:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:26.00%;top:43.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:26.00%;top:43.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:26.00%;top:48.00%;width:44.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:20.00%;height:28.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:20.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:38.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:56.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:26.00%;top:64.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:26.00%;top:76.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:76.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:72.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:78.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:78.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:84.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:26%;--y:6%;--nw:18%\"\u003eUDI Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:26%;--y:24%;--nw:20%\"\u003eApply for GS1 Membership\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:26%;--y:43%;--nw:21%\"\u003eMembership Certificate \/ Prefix\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:26%;--y:64%;--nw:20%\"\u003eCreate Device Identifier (DI)\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:20%;--nw:21%\"\u003eApply for GUDID CRD Account\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:38%;--nw:21%\"\u003eApply for GUDID IDE Account\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:56%;--nw:21%\"\u003eComplete GUDID IDE Account\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:72%;--nw:18%\"\u003eConfirm GMDN Code\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:84%;--nw:23%\"\u003eEnter Device Data into GUDID\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:48%;--y:96%;--nw:18%\"\u003eUDI Setup Complete\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-801\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 801\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eMedical-device labeling requirements, including UDI-related labeling provisions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-H\/part-830\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003e21 CFR Part 830\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eUnique Device Identification requirements and GUDID framework.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/medical-devices\/unique-device-identification-system-udi-system\/udi-basics\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA UDI Basics\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial FDA overview of the UDI system and core obligations.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.fda.gov\/medical-devices\/unique-device-identification-system-udi-system\/global-unique-device-identification-database-gudid\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eFDA Global UDI Database (GUDID)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial FDA GUDID information and submission resources.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eFDA device listing and premarket submission support can be coordinated with UDI work where needed.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"UDI \/ GUDID Support","offer_id":47472020357276,"sku":"REG-FDA-UDI","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"health-canada-medical-device-registration-service","title":"Health Canada Medical Device Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; 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color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-health-canada-medical-device-registration-service-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-health-canada-medical-device-registration-service-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-health-canada-medical-device-registration-service-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-health-canada-medical-device-registration-service-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-health-canada-medical-device-registration-service-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-health-canada-medical-device-registration-service-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} .eximio-product-description #eximio-health-canada-medical-device-registration-service-3:checked ~ .eximio-flow-tab-nav label[for=\"eximio-health-canada-medical-device-registration-service-3\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-health-canada-medical-device-registration-service-3:checked ~ .eximio-flow-panels .eximio-flow-panel-3{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eHealth Canada applies a risk-based classification system for medical devices. EXIMIO can organize the registration route around the applicable device class, including establishment licensing, device licensing, quality-system evidence and submission coordination represented in the source workflows.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-health-canada-medical-device-registration-service-1\" name=\"eximio-v6-flow-health-canada-medical-device-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-health-canada-medical-device-registration-service-2\" name=\"eximio-v6-flow-health-canada-medical-device-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-health-canada-medical-device-registration-service-3\" name=\"eximio-v6-flow-health-canada-medical-device-registration-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-health-canada-medical-device-registration-service-1\"\u003eClass I\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-health-canada-medical-device-registration-service-2\"\u003eClass II\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-health-canada-medical-device-registration-service-3\"\u003eClass III–IV\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass I\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eOfficial authority service standard\u003c\/span\u003e\u003cstrong\u003e120 calendar days\u003c\/strong\u003e\u003csmall\u003eOfficial authority standard (MDEL)\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.62\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:6.00%;height:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:25.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:45.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:65.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:82.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:6%;--nw:24%\"\u003eHealth Canada Class I Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:25%;--nw:22%\"\u003eCompany MDEL Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:45%;--nw:23%\"\u003ePrepare MDEL Application Materials\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:65%;--nw:22%\"\u003eSubmit Application \u0026amp; Pay Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:82%;--nw:19%\"\u003eHealth Canada Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:95%;--nw:19%\"\u003eMDEL \/ Authorization\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass II\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eOfficial MDL review standard\u003c\/span\u003e\u003cstrong\u003e15 calendar days\u003c\/strong\u003e\u003csmall\u003eOfficial authority standard\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.85\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:12.00%;width:32.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:12.00%;width:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:30.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:12.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:20.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:38.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:56.00%;height:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:20.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:37.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:54.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:70.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:22.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:40.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:58.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:34.00%;height:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:34.00%;width:32.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:34.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:75.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:87.00%;width:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:35.00%;top:87.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:84.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:35.00%;top:89.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:35.00%;top:89.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:5%;--nw:24%\"\u003eHealth Canada Class II Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:20%;--nw:20%\"\u003eCompany MDEL Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:38%;--nw:20%\"\u003ePrepare MDEL Materials\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:56%;--nw:18%\"\u003eSubmit \u0026amp; Pay Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:75%;--nw:18%\"\u003eMDEL Review Passed\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:20%;--nw:20%\"\u003eProduct MDL Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:37%;--nw:19%\"\u003eMDSAP Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:54%;--nw:20%\"\u003ePrepare MDL Materials\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:70%;--nw:18%\"\u003eSubmit \u0026amp; Pay Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:84%;--nw:18%\"\u003eMDL Review Passed\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:80%;--y:22%;--nw:18%\"\u003eEstablish QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:80%;--y:40%;--nw:20%\"\u003eCertification Body Audit\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:80%;--y:58%;--nw:18%\"\u003eCorrective Actions\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:80%;--y:74%;--nw:18%\"\u003eCertificate Issued\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:35%;--y:95%;--nw:24%\"\u003eMarket Authorization \/ Certificate\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass III–IV\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eOfficial MDL review standards\u003c\/span\u003e\u003cstrong\u003eClass III 60 · Class IV 75 days\u003c\/strong\u003e\u003csmall\u003eOfficial authority standard\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map\" style=\"--flow-ratio:0.84\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:5.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:17.00%;top:12.00%;width:33.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:17.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:12.00%;width:2.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:32.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:17.00%;top:20.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:17.00%;top:38.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:17.00%;top:56.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:20.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:35.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:50.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:42.00%;top:58.00%;width:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:42.00%;top:58.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:58.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:58.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:42.00%;top:66.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:42.00%;top:75.00%;width:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:75.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:66.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:75.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:82.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:20.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:38.00%;height:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:56.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:32.00%;height:40.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:48.00%;top:32.00%;width:34.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:48.00%;top:32.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:17.00%;top:78.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:17.00%;top:88.00%;width:33.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:88.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:5%;--nw:25%\"\u003eHealth Canada Class III \/ IV Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:17%;--y:20%;--nw:20%\"\u003eCompany MDEL Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:17%;--y:38%;--nw:20%\"\u003ePrepare MDEL Materials\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:17%;--y:56%;--nw:18%\"\u003eSubmit \u0026amp; Pay Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:17%;--y:78%;--nw:18%\"\u003eMDEL Review Passed\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:20%;--nw:20%\"\u003eProduct MDL Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:35%;--nw:19%\"\u003eMDSAP Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:48%;--y:50%;--nw:20%\"\u003ePrepare MDL Materials\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:42%;--y:66%;--nw:17%\"\u003eApplication \u0026amp; Fee\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:66%;--nw:19%\"\u003ePremarket Review File\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:82%;--nw:20%\"\u003eHealth Canada MDL Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:20%;--nw:18%\"\u003eEstablish QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:38%;--nw:20%\"\u003eCertification Body Audit\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:56%;--nw:18%\"\u003eCorrective Actions\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:82%;--y:72%;--nw:18%\"\u003eCertificate Issued\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:96%;--nw:19%\"\u003eMDL \/ Certificate\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-98-282\/\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMedical Devices Regulations (SOR\/98-282)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent consolidated Canadian medical-device regulation.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-98-282\/section-25.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eSOR\/98-282 §25\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eClass I sale\/import licensing framework and applicable exceptions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-98-282\/section-26.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eSOR\/98-282 §26\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eRequirement for Class II, III and IV medical devices to hold a medical device licence before import\/sale, subject to the regulation.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-98-282\/section-32.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eSOR\/98-282 §32\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eRequired content for an application for a medical device licence.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/laws-lois.justice.gc.ca\/eng\/regulations\/SOR-98-282\/section-44.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eSOR\/98-282 §44\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eMedical Device Establishment Licence (MDEL) requirement and exceptions.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/application-information\/guidance-documents\/managing-applications-licenses\/review-process.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eHealth Canada MDL Review Process\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent review stages and Class III \/ IV target performance standards.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/publications\/drugs-health-products\/performance-fees-drugs-medical-devices.html\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003ePerformance Standards for Medical-Device Fees\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial Class II–IV MDL and MDEL performance standards.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eClassification review, MDSAP preparation and technical-document support can be coordinated with the registration service.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Class I","offer_id":47472020390044,"sku":"REG-HC-I","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class II","offer_id":47472020422812,"sku":"REG-HC-II","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class III–IV","offer_id":47472020455580,"sku":"REG-HC-III-IV","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"eu-ivdr-ce-registration-service","title":"EU IVDR CE Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-eu-ivdr-ce-registration-service-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-3:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-3\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-3:checked ~ .eximio-flow-panels .eximio-flow-panel-3{display:block} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-4:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-4\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-4:checked ~ .eximio-flow-panels .eximio-flow-panel-4{display:block} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-5:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-5\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-5:checked ~ .eximio-flow-panels .eximio-flow-panel-5{display:block} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-6:checked ~ .eximio-flow-tab-nav label[for=\"eximio-eu-ivdr-ce-registration-service-6\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-eu-ivdr-ce-registration-service-6:checked ~ .eximio-flow-panels .eximio-flow-panel-6{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO supports IVD manufacturers preparing for CE market access under the EU IVDR. The product combines the six source workflows into one service page so customers can select the correct class and conformity-assessment route without duplicating nearly identical product pages.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-1\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-2\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-3\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-4\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-5\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-eu-ivdr-ce-registration-service-6\" name=\"eximio-v6-flow-eu-ivdr-ce-registration-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-1\"\u003eClass A\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-2\"\u003eClass B\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-3\"\u003eClass C – QMS + Technical Documentation\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-4\"\u003eClass C – EC Type Examination + Production QA\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-5\"\u003eClass D – QMS + Technical Documentation\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-eu-ivdr-ce-registration-service-6\"\u003eClass D – EC Type Examination + Production QA\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass A\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~90 days non-sterile · longer for sterile\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.92\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:52.00%;top:4.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:52.00%;top:14.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:38.00%;top:20.00%;width:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:52.00%;top:20.00%;width:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:30.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:36.00%;width:28.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:36.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:10.00%;top:48.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:10.00%;top:48.00%;width:28.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:43.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:27.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:43.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:58.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:68.00%;width:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:68.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:38.00%;top:68.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:47.00%;top:68.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:76.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:85.00%;width:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:85.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:47.00%;top:76.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:38.00%;top:85.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:27.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:43.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:43.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:52.00%;width:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:52.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:60.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:64.00%;top:69.00%;width:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:69.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:69.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:69.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:64.00%;top:77.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:64.00%;top:86.00%;width:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:86.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:80.00%;top:77.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:72.00%;top:86.00%;width:8.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:52%;--y:4%;--nw:22%\"\u003eEU IVDR Class A Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:52%;--y:14%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:10%;--y:30%;--nw:21%\"\u003ePerformance Evaluation \/ PMS \/ PMPF\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:10%;--y:52%;--nw:17%\"\u003eMaintain QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:38%;--y:27%;--nw:19%\"\u003eClass A — Non-Sterile\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:38%;--y:43%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:38%;--y:58%;--nw:20%\"\u003eEU Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:76%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:47%;--y:76%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:38%;--y:92%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:27%;--nw:18%\"\u003eClass A — Sterile\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:43%;--nw:19%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:43%;--nw:19%\"\u003eISO QMS \/ Sterile Controls\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:60%;--nw:22%\"\u003eNotified Body (Sterile Aspects)\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:64%;--y:77%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:80%;--y:77%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:72%;--y:93%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass B\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e90–180 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.78\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:32.00%;top:19.00%;width:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:19.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:69.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:16.00%;top:39.00%;width:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:39.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:69.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:57.00%;top:39.00%;width:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:69.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:69.00%;top:39.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:32.00%;top:52.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:32.00%;top:58.00%;width:18.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:58.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:69.00%;top:52.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:58.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:64.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:74.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:83.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:87.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:87.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:87.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:87.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:91.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:95.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:95.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:91.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:95.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:22%\"\u003eEU IVDR Class B Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:32%;--y:25%;--nw:18%\"\u003eProfessional-Use IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:16%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:32%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:32%;--y:52%;--nw:18%\"\u003ePerformance Evaluation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:69%;--y:25%;--nw:20%\"\u003eSelf-Test \/ Near-Patient IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:57%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:69%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:84%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:69%;--y:52%;--nw:21%\"\u003eTechnical Documentation Evaluation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:64%;--nw:20%\"\u003eEU Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:74%;--nw:19%\"\u003eNotified Body Assessment\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:83%;--nw:18%\"\u003eCE \/ ISO Certificates\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:41%;--y:91%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:91%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass C – QMS + Technical Documentation\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e90–180 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.78\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:19.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:19.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:16.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:57.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:49.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:49.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:49.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:55.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:66.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:76.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:85.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:89.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:89.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:95.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:95.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:95.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:25%\"\u003eEU IVDR Class C — QMS + Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:25%;--nw:18%\"\u003eProfessional-Use IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:16%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:44%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:25%;--nw:20%\"\u003eSelf-Test \/ Near-Patient IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:57%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:85%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:55%;--nw:22%\"\u003eTechnical Documentation Evaluation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:66%;--nw:20%\"\u003eEU Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:76%;--nw:19%\"\u003eNotified Body Assessment\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:85%;--nw:18%\"\u003eCE \/ ISO Certificates\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:41%;--y:92%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:92%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass C – EC Type Examination + Production QA\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e90–180 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.78\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:19.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:19.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:16.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:57.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:49.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:49.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:49.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:55.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:65.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:75.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:84.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:89.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:89.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:95.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:95.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:95.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:26%\"\u003eEU IVDR Class C — EC Type Examination + Production QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:25%;--nw:18%\"\u003eProfessional-Use IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:16%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:44%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:25%;--nw:20%\"\u003eSelf-Test \/ Near-Patient IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:57%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:85%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:50%;--y:55%;--nw:19%\"\u003eEC Type Examination\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:65%;--nw:21%\"\u003eType-Examination Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:75%;--nw:23%\"\u003eProduction Quality-Assurance Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:84%;--nw:24%\"\u003eEU Authorized Representative \/ Notified Body\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:41%;--y:92%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:92%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass D – QMS + Technical Documentation\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e90–180 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.78\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:19.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:19.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:16.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:57.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:49.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:49.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:49.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:55.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:66.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:76.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:85.00%;height:4.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:89.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:89.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:95.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:95.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:95.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:25%\"\u003eEU IVDR Class D — QMS + Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:25%;--nw:18%\"\u003eProfessional-Use IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:16%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:44%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:25%;--nw:20%\"\u003eSelf-Test \/ Near-Patient IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:57%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:85%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:55%;--nw:22%\"\u003eTechnical Documentation Evaluation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:66%;--nw:20%\"\u003eEU Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:76%;--nw:21%\"\u003eNotified Body \/ Class D Assessment\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:85%;--nw:18%\"\u003eCE \/ ISO Certificates\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:41%;--y:92%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:92%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass D – EC Type Examination + Production QA\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e90–180 days\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.78\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:19.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:19.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:19.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:16.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:25.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:57.00%;top:39.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:70.00%;top:39.00%;width:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:31.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:31.00%;top:49.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:49.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:70.00%;top:39.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:49.00%;width:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:55.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:65.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:75.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:84.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:89.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:89.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:89.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:41.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:41.00%;top:95.00%;width:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:95.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:60.00%;top:92.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:95.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:26%\"\u003eEU IVDR Class D — EC Type Examination + Production QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:17%\"\u003eAppoint PRRC\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:25%;--nw:18%\"\u003eProfessional-Use IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:16%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:31%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:44%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:25%;--nw:20%\"\u003eSelf-Test \/ Near-Patient IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:57%;--y:39%;--nw:18%\"\u003eAdministrative Requirements\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:70%;--y:39%;--nw:20%\"\u003eProduct Technical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:85%;--y:39%;--nw:15%\"\u003eISO QMS\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:50%;--y:55%;--nw:19%\"\u003eEC Type Examination\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:65%;--nw:21%\"\u003eType-Examination Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:75%;--nw:23%\"\u003eProduction Quality-Assurance Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:84%;--nw:24%\"\u003eEU Authorized Representative \/ Notified Body\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:41%;--y:92%;--nw:18%\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:60%;--y:92%;--nw:15%\"\u003eObtain UDI\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:19%\"\u003eRegistration Approved\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eRegulation (EU) 2017\/746 (IVDR)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial Journal legal act; use Article 47 (classification), Article 48 (conformity assessment), Annex VIII and Annexes IX–XI for the routes shown.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:02017R0746-20250110\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eIVDR — current consolidated text\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eConsolidated IVDR text current to 10 January 2025 on EUR-Lex.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eEU Authorized Representative coordination, QMS preparation, performance-evaluation documentation, UDI support and technical-document review can be included in the project scope.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Class A","offer_id":47472020488348,"sku":"REG-IVDR-A","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class B","offer_id":47472020521116,"sku":"REG-IVDR-B","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class C – QMS + Technical Documentation","offer_id":47472020553884,"sku":"REG-IVDR-C-QMS-TD","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class C – EC Type Examination + Production QA","offer_id":47472020586652,"sku":"REG-IVDR-C-EC-PQA","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class D – QMS + Technical Documentation","offer_id":47472020619420,"sku":"REG-IVDR-D-QMS-TD","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"Class D – EC Type Examination + Production QA","offer_id":47472020652188,"sku":"REG-IVDR-D-EC-PQA","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"brazil-anvisa-medical-device-registration-service","title":"Brazil ANVISA Medical Device Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description 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.eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; 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content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO can support manufacturers preparing medical devices for the Brazilian market by organizing product classification, required local certifications, quality-system evidence, technical documentation and ANVISA submission steps. The original source uses one combined workflow because the core process branches mainly by device risk class.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-brazil-anvisa-medical-device-registration-service-1\" name=\"eximio-v6-flow-brazil-anvisa-medical-device-registration-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-brazil-anvisa-medical-device-registration-service-1\"\u003eClass I–IV Registration\u003c\/label\u003e\u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e\u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eClass I–IV Registration\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timing\u003c\/span\u003e\u003cstrong\u003e~90-day certification branch; total varies\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.88\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:13.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:12.00%;top:20.00%;width:38.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:12.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:37.00%;top:20.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:20.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:20.00%;width:38.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:88.00%;top:20.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:12.00%;top:27.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:12.00%;top:48.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:12.00%;top:68.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:27.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:43.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:58.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:72.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:27.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:43.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:58.00%;height:14.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:72.00%;height:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:88.00%;top:27.00%;height:21.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:88.00%;top:48.00%;height:20.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:88.00%;top:68.00%;height:16.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:12.00%;top:84.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:12.00%;top:90.00%;width:38.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:90.00%;height:3.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:37.00%;top:85.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:37.00%;top:90.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:63.00%;top:85.00%;height:5.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:90.00%;width:13.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:88.00%;top:84.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:90.00%;width:38.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:93.00%;height:6.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:20%\"\u003eANVISA Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:19%\"\u003eProduct Classification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:12%;--y:27%;--nw:14%\"\u003eClass I\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:37%;--y:27%;--nw:14%\"\u003eClass II\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:27%;--nw:14%\"\u003eClass III\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:88%;--y:27%;--nw:14%\"\u003eClass IV\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:12%;--y:48%;--nw:19%\"\u003eBGMP Exemption \/ Applicability\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:12%;--y:68%;--nw:18%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:12%;--y:84%;--nw:20%\"\u003eBrazil Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:37%;--y:43%;--nw:18%\"\u003eINMETRO Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:37%;--y:58%;--nw:18%\"\u003eBGMP Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:37%;--y:72%;--nw:18%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:37%;--y:85%;--nw:20%\"\u003eBrazil Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:43%;--nw:18%\"\u003eINMETRO Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:58%;--nw:18%\"\u003eBGMP Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:72%;--nw:18%\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:63%;--y:85%;--nw:20%\"\u003eBrazil Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:88%;--y:48%;--nw:21%\"\u003eBGMP \/ INMETRO as Applicable\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:88%;--y:68%;--nw:22%\"\u003eClinical Evidence \/ Trial as Applicable\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:88%;--y:84%;--nw:20%\"\u003eBrazil Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:93%;--nw:21%\"\u003eSubmit ANVISA Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:99%;--nw:18%\"\u003eRegistration Approval\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.br\/anvisa\/en\/rules-and-regulations\/arquivos\/rdc-751_2022.pdf\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eANVISA RDC No. 751\/2022\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eRisk classification, notification and marketing-authorization rules for medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.br\/anvisa\/en\/rules-and-regulations\/arquivos\/rdc_830_2023-e.pdf\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eANVISA RDC No. 830\/2023\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eRisk classification, notification and marketing-authorization rules for in vitro diagnostic medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.br\/anvisa\/en\/regulation-of-products\/medical-devices\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eANVISA Medical Devices\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent ANVISA medical-device regulatory overview and applicable RDC references.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eProduct classification, INMETRO-related coordination, quality-system documentation and Brazilian local-holder support can be included depending on device type.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Class I–IV Registration","offer_id":47472020881564,"sku":"REG-ANVISA-MD","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"uk-mhra-ivd-registration-service","title":"UK MHRA IVD Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v6-original-layout-refined\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } .eximio-product-description #eximio-uk-mhra-ivd-registration-service-1:checked ~ .eximio-flow-tab-nav label[for=\"eximio-uk-mhra-ivd-registration-service-1\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-1:checked ~ .eximio-flow-panels .eximio-flow-panel-1{display:block} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-2:checked ~ .eximio-flow-tab-nav label[for=\"eximio-uk-mhra-ivd-registration-service-2\"]{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff} .eximio-product-description #eximio-uk-mhra-ivd-registration-service-2:checked ~ .eximio-flow-panels .eximio-flow-panel-2{display:block} \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e\u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eThe source workbook separates higher-risk legacy List A\/List B routes from General and Self-test IVD routes. For Shopify, these are better presented as variants of one UK MHRA IVD registration product, with the final conformity and registration route confirmed against the rules applicable to the device at the time of the project.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-uk-mhra-ivd-registration-service-1\" name=\"eximio-v6-flow-uk-mhra-ivd-registration-service\" type=\"radio\"\u003e\u003cinput class=\"eximio-flow-control\" id=\"eximio-v6-uk-mhra-ivd-registration-service-2\" name=\"eximio-v6-flow-uk-mhra-ivd-registration-service\" type=\"radio\"\u003e\u003cdiv aria-label=\"Service route\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-uk-mhra-ivd-registration-service-1\"\u003eHigher-Risk IVD (Source: List A \/ List B)\u003c\/label\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-uk-mhra-ivd-registration-service-2\"\u003eGeneral \/ Self-test IVD\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eHigher-Risk IVD (Source: List A \/ List B)\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~12 months\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.0\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:12.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:12.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:20.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:38.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:49.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:49.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:38.00%;top:38.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:49.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:20.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:61.00%;top:29.00%;width:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:61.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:72.00%;top:29.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:29.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:61.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:61.00%;top:50.00%;width:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:50.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:82.00%;top:38.00%;height:12.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:72.00%;top:50.00%;width:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28.00%;top:76.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28.00%;top:84.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:84.00%;height:7.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72.00%;top:62.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:84.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:24%\"\u003eMHRA Registration — Source List A \/ List B\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:20%;--nw:16%\"\u003eList A IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:20%;--nw:16%\"\u003eList B IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:38%;--nw:20%\"\u003eFull Quality-Assurance System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:38%;--y:38%;--nw:20%\"\u003eProduct Design-Dossier Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:59%;--nw:19%\"\u003eFinished-Product Verification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:61%;--y:38%;--nw:20%\"\u003eFull Quality-Assurance System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:82%;--y:38%;--nw:22%\"\u003eEC Sample Examination \/ Product QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:62%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eGeneral \/ Self-test IVD\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~11 months\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e\u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:1.12\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50.00%;top:4.00%;height:8.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:18.00%;top:12.00%;width:32.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50.00%;top:12.00%;width:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:67.00%;top:12.00%;height:9.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:21.00%;height:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:18.00%;top:43.00%;height:27.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:67.00%;top:21.00%;height:10.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:45.00%;top:31.00%;width:22.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:66.00%;top:31.00%;width:1.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:67.00%;top:31.00%;width:19.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:31.00%;height:11.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:42.00%;height:23.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:45.00%;top:65.00%;height:26.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:42.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:66.00%;top:76.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:42.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:59.00%;height:17.00%\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:86.00%;top:76.00%;height:15.00%\"\u003e\u003c\/span\u003e\u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:24%\"\u003eMHRA Registration — General \/ Self-Test IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:21%;--nw:16%\"\u003eGeneral IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:67%;--y:21%;--nw:17%\"\u003eSelf-Test IVD\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:18%;--y:43%;--nw:18%\"\u003eConformity Declaration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:18%;--y:70%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:45%;--y:42%;--nw:17%\"\u003eFull QA System\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:42%;--nw:19%\"\u003eEC Sample Examination\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:42%;--nw:18%\"\u003eConformity Declaration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:45%;--y:65%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:59%;--nw:22%\"\u003eEC Verification \/ Production QA\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:59%;--nw:19%\"\u003eProduct Design Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:66%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:86%;--y:76%;--nw:19%\"\u003eUK Approved Body Review\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:45%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:66%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:86%;--y:91%;--nw:18%\"\u003eUKCA Certification\u003c\/div\u003e \u003c\/div\u003e\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e\u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/contents\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eUK Medical Devices Regulations 2002 (SI 2002\/618)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent official legislation record for the UK medical-device framework.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.uk\/uksi\/2002\/618\/part\/IV\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eUK MDR 2002 — Part IV (IVDs)\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eDirect official Part IV provisions for in vitro diagnostic medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/guidance\/register-medical-devices-to-place-on-the-market\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — Register medical devices to place on the market\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent Great Britain registration requirements, including IVDs; last updated July 2026.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/guidance\/regulating-medical-devices-in-the-uk\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — Regulating medical devices in the UK\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent overview of GB, Northern Ireland, UKCA and CE transition arrangements.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.gov.uk\/government\/publications\/in-vitro-diagnostic-medical-devices-guidance-on-legislation\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eMHRA — IVD legislation guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial guidance on legal routes for in vitro diagnostic medical devices.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e\u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eUK Responsible Person coordination, technical-document review, QMS preparation and conformity-assessment support can be included in project scope where applicable.\u003c\/p\u003e \u003c\/section\u003e\u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Higher-Risk IVD (Source: List A \/ List B)","offer_id":47472020914332,"sku":"REG-MHRA-HR-IVD","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"General \/ Self-test IVD","offer_id":47472020947100,"sku":"REG-MHRA-GEN-ST","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"australia-tga-medical-device-registration-service","title":"Australia TGA Medical Device Registration Service","description":"\u003cstyle\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e \u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO can support manufacturers preparing devices for entry into the Australian market by organizing classification, conformity-assessment evidence, technical documentation and the TGA\/ARTG application workflow. The source diagram branches by Class I status, manufacturing location and special-material conditions.\u003c\/p\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect a route below to view the workflow and timing.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-v6-australia-tga-medical-device-registration-service-1\" name=\"eximio-v6-flow-australia-tga-medical-device-registration-service\" type=\"radio\"\u003e \u003cdiv class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e\u003clabel class=\"eximio-flow-tab\" for=\"eximio-v6-australia-tga-medical-device-registration-service-1\"\u003eTGA \/ ARTG Registration\u003c\/label\u003e\u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eTGA \/ ARTG Registration\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eIndicative source timeline\u003c\/span\u003e\u003cstrong\u003e~1 month some Class I · ~2–3 months other routes\u003c\/strong\u003e\u003csmall\u003eSource estimate; not statutory\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e \u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio: 0.95;\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 50.00%; top: 3.00%; height: 8.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 50.00%; top: 11.00%; height: 7.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left: 11.00%; top: 18.00%; width: 39.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 18.00%; height: 6.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left: 37.00%; top: 18.00%; width: 13.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 18.00%; height: 6.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left: 50.00%; top: 18.00%; width: 13.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 18.00%; height: 6.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left: 50.00%; top: 18.00%; width: 39.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 18.00%; height: 6.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 24.00%; height: 15.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 39.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 53.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 67.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 11.00%; top: 81.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 24.00%; height: 15.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 39.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 53.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 67.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 37.00%; top: 81.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 24.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 38.00%; height: 13.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 51.00%; height: 13.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 64.00%; height: 13.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 77.00%; height: 11.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 63.00%; top: 88.00%; height: 10.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 24.00%; height: 15.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 39.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 53.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 67.00%; height: 14.00%;\"\u003e\u003c\/span\u003e\u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left: 89.00%; top: 81.00%; height: 14.00%;\"\u003e\u003c\/span\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x: 50%; --y: 3%; --nw: 18%;\"\u003eTGA Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 50%; --y: 11%; --nw: 18%;\"\u003eProduct Classification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 11%; --y: 24%; --nw: 20%;\"\u003eClass I — Non-Sterile \/ Non-Measuring\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 11%; --y: 39%; --nw: 18%;\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 11%; --y: 53%; --nw: 18%;\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 11%; --y: 67%; --nw: 20%;\"\u003eAustralian Sponsor \/ Authorization\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 11%; --y: 81%; --nw: 19%;\"\u003eTGA eBS \/ ARTG Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x: 11%; --y: 95%; --nw: 20%;\"\u003eARTG Inclusion Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 37%; --y: 24%; --nw: 20%;\"\u003eOther Class I — Australian Manufacture\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 37%; --y: 39%; --nw: 21%;\"\u003eConformity-Assessment Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 37%; --y: 53%; --nw: 22%;\"\u003eTGA Conformity-Assessment Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 37%; --y: 67%; --nw: 18%;\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 37%; --y: 81%; --nw: 19%;\"\u003eTGA eBS \/ ARTG Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x: 37%; --y: 95%; --nw: 20%;\"\u003eARTG Inclusion Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 24%; --nw: 20%;\"\u003eOther Class I — Overseas Manufacture\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 38%; --nw: 18%;\"\u003eTechnical Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 51%; --nw: 20%;\"\u003eOverseas Conformity Evidence\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 64%; --nw: 18%;\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 77%; --nw: 20%;\"\u003eTGA Technical Review if Applicable\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 63%; --y: 88%; --nw: 19%;\"\u003eTGA eBS \/ ARTG Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x: 63%; --y: 98%; --nw: 20%;\"\u003eARTG Inclusion Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 89%; --y: 24%; --nw: 20%;\"\u003eHigher-Risk \/ Special-Material Route\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 89%; --y: 39%; --nw: 21%;\"\u003eConformity-Assessment Documentation\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 89%; --y: 53%; --nw: 22%;\"\u003eTGA Conformity-Assessment Certificate\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 89%; --y: 67%; --nw: 18%;\"\u003eDeclaration of Conformity\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x: 89%; --y: 81%; --nw: 19%;\"\u003eTGA eBS \/ ARTG Application\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x: 89%; --y: 95%; --nw: 20%;\"\u003eARTG Inclusion Certificate\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eLegal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.au\/C2004A03952\/latest\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eTherapeutic Goods Act 1989\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003ePrimary Australian therapeutic-goods statute governing ARTG supply framework.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.legislation.gov.au\/F2002B00237\/latest\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eTherapeutic Goods (Medical Devices) Regulations 2002\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eCurrent medical-device regulations on the Australian Federal Register of Legislation.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e\u003ca class=\"eximio-reg-card\" href=\"https:\/\/www.tga.gov.au\/products\/medical-devices\/application-and-market-authorisation\/supply-medical-device\/medical-device-inclusion-process\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e\u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e\u003cspan class=\"eximio-reg-title\"\u003eTGA Medical Device Inclusion Process\u003c\/span\u003e\u003cspan class=\"eximio-reg-scope\"\u003eOfficial steps for including medical devices and IVDs in the ARTG.\u003c\/span\u003e\u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e\u003c\/a\u003e \u003c\/div\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eClassification review, conformity-evidence planning, technical-document preparation and Australian sponsor coordination can be included as needed.\u003c\/p\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"TGA \/ ARTG Registration","offer_id":47472020979868,"sku":"REG-TGA-MD","price":0.0,"currency_code":"CNY","in_stock":true}]},{"product_id":"russia-eaeu-medical-device-registration-service","title":"Russia \/ EAEU Medical Device Registration Service","description":"\u003cstyle data-eximio-product-css=\"blue-v7-simplified-flow\"\u003e .eximio-product-description{ --eximio-blue:#1f5fbf;--eximio-blue-dark:#123e73;--eximio-blue-soft:#f4f8fd; --eximio-text:#334155;--eximio-overview-text:#365777;--eximio-muted:#64748b; --eximio-line:#dbe5f1;--eximio-surface:#f8fafc; width:100%;max-width:none;margin:0;color:var(--eximio-text);font-size:16px;line-height:1.72; -webkit-font-smoothing:antialiased; } .eximio-product-description,.eximio-product-description *{box-sizing:border-box} .eximio-product-description .eximio-product-section{margin:0;padding:25px 0;border:0;background:transparent} .eximio-product-description .eximio-product-section:first-child{padding-top:0} .eximio-product-description .eximio-product-overview{padding-bottom:24px} .eximio-product-description .eximio-product-heading{ display:block;margin:0 0 17px;padding:0 0 10px;color:var(--eximio-blue-dark); border:0;border-bottom:1px solid var(--eximio-line);font-size:clamp(19px,1.7vw,22px); font-weight:650;line-height:1.35;letter-spacing:-.01em } .eximio-product-description p{margin:0 0 13px;color:var(--eximio-text)} .eximio-product-description p:last-child{margin-bottom:0} .eximio-product-description .eximio-product-overview\u003ep{ max-width:920px;color:var(--eximio-overview-text);font-size:17px;line-height:1.82 } .eximio-product-description strong{color:var(--eximio-blue-dark);font-weight:650} .eximio-product-description .eximio-product-table{ width:100%;max-width:100%;margin:16px 0 4px;border:1px solid var(--eximio-line); border-radius:8px;border-collapse:separate;border-spacing:0;background:#fff;table-layout:fixed } .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{ padding:12px 14px;border-right:1px solid var(--eximio-line);border-bottom:1px solid var(--eximio-line); vertical-align:top;text-align:left;font-size:14px;line-height:1.55;overflow-wrap:anywhere } .eximio-product-description .eximio-product-table th{color:var(--eximio-blue-dark);font-weight:650;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-product-table tbody tr:nth-child(even) td{background:var(--eximio-surface)} .eximio-product-description .eximio-product-table tr:last-child\u003e*{border-bottom:0} .eximio-product-description .eximio-product-table tr\u003e*:last-child{border-right:0} .eximio-product-description .eximio-process-intro{max-width:920px;color:var(--eximio-muted)} .eximio-product-description .eximio-route-flow{ margin:20px 0 28px;padding:18px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-route-title{ margin:0 0 6px;color:var(--eximio-blue-dark);font-size:18px;font-weight:650;line-height:1.35 } .eximio-product-description .eximio-route-meta{margin:0 0 15px;color:var(--eximio-muted);font-size:13px} .eximio-product-description .eximio-process{ display:flex;align-items:stretch;gap:8px;overflow-x:auto;padding:2px 0 8px;-webkit-overflow-scrolling:touch } .eximio-product-description .eximio-process-step{ flex:1 0 150px;min-width:150px;padding:13px 12px;border:1px solid #c9daf0;border-radius:9px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;line-height:1.45; display:flex;align-items:center;justify-content:center;text-align:center;font-weight:600 } .eximio-product-description .eximio-process-arrow{ flex:0 0 20px;display:flex;align-items:center;justify-content:center;color:var(--eximio-blue); font-size:20px;font-weight:700 } .eximio-product-description .eximio-note{ margin-top:14px;padding:12px 14px;border-left:3px solid var(--eximio-blue); background:var(--eximio-surface);color:var(--eximio-muted);font-size:13px;line-height:1.55 } @media(max-width:749px){ .eximio-product-description{font-size:15px;line-height:1.68} .eximio-product-description .eximio-product-section{padding:21px 0} .eximio-product-description .eximio-product-heading{margin-bottom:13px;padding-bottom:8px;font-size:18px} .eximio-product-description .eximio-product-overview\u003ep{font-size:16px;line-height:1.76} .eximio-product-description .eximio-product-table th, .eximio-product-description .eximio-product-table td{padding:9px 8px;font-size:12px;line-height:1.4} .eximio-product-description .eximio-route-flow{padding:14px 12px;margin:16px 0 22px} .eximio-product-description .eximio-route-title{font-size:16px} .eximio-product-description .eximio-process{flex-direction:column;overflow:visible;gap:4px} .eximio-product-description .eximio-process-step{flex:0 0 auto;min-width:0;width:100%;min-height:54px} .eximio-product-description .eximio-process-arrow{height:20px;transform:rotate(90deg)} } \/* CSS-only flow switcher: no JavaScript *\/ .eximio-product-description .eximio-flow-switcher{margin:18px 0 6px} .eximio-product-description .eximio-flow-control{ position:absolute!important;width:1px!important;height:1px!important;margin:-1px!important;padding:0!important; overflow:hidden!important;clip:rect(0 0 0 0)!important;white-space:nowrap!important;border:0!important;opacity:0!important } .eximio-product-description .eximio-flow-tab-nav{ display:flex;gap:8px;overflow-x:auto;padding:2px 1px 10px;-webkit-overflow-scrolling:touch;scrollbar-width:thin } .eximio-product-description .eximio-flow-tab{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-height:42px;padding:9px 14px; border:1px solid var(--eximio-line);border-radius:999px;background:#fff;color:var(--eximio-blue-dark); font-size:13px;font-weight:650;line-height:1.25;cursor:pointer;transition:border-color .18s ease,background .18s ease,color .18s ease } .eximio-product-description .eximio-flow-tab:hover{border-color:#9dbde4;background:var(--eximio-blue-soft)} .eximio-product-description .eximio-flow-panels{margin-top:2px} .eximio-product-description .eximio-flow-panel{ display:none;margin:0;padding:18px;border:1px solid var(--eximio-line);border-radius:12px;background:#fff } .eximio-product-description .eximio-flow-panel.is-single{display:block} .eximio-product-description .eximio-flow-head{ display:flex;align-items:flex-start;justify-content:space-between;gap:18px;margin:0 0 15px;padding:0 0 14px; border-bottom:1px solid var(--eximio-line) } .eximio-product-description .eximio-flow-head .eximio-route-title{margin:2px 0 0} .eximio-product-description .eximio-flow-timing{ flex:0 0 min(340px,46%);padding:10px 12px;border:1px solid #c9daf0;border-radius:9px;background:var(--eximio-blue-soft) } .eximio-product-description .eximio-flow-timing-label{ display:block;margin:0 0 2px;color:var(--eximio-muted);font-size:11px;font-weight:700;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-flow-timing strong{ display:block;color:var(--eximio-blue-dark);font-size:15px;line-height:1.35 } .eximio-product-description .eximio-flow-timing small{ display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;line-height:1.4 } .eximio-product-description .eximio-flow-panel .eximio-process{margin-top:0} .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;flex-direction:column;gap:5px;padding:32px 12px 13px;justify-content:flex-start } .eximio-product-description .eximio-step-number{ position:absolute;top:8px;left:9px;display:inline-flex;align-items:center;justify-content:center;min-width:22px;height:20px;padding:0 5px; border-radius:999px;background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;line-height:1 } .eximio-product-description .eximio-step-copy{display:block} .eximio-product-description .eximio-step-time{ display:inline-flex;align-items:center;margin-top:3px;padding:3px 7px;border-radius:999px;background:#e8f1fc;color:var(--eximio-blue-dark); font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-flow-note{margin:12px 0 0;color:var(--eximio-muted);font-size:12px;line-height:1.55} .eximio-product-description .eximio-timing-key{ margin:12px 0 0;padding:10px 12px;border-left:3px solid var(--eximio-blue);background:var(--eximio-surface); color:var(--eximio-muted);font-size:12px;line-height:1.55 } .eximio-product-description .eximio-regulatory-grid{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:10px;margin:15px 0 0 } .eximio-product-description .eximio-reg-card{ display:block;padding:14px 15px;border:1px solid var(--eximio-line);border-radius:10px;background:#fff; color:inherit;text-decoration:none!important;transition:border-color .18s ease,box-shadow .18s ease,transform .18s ease } .eximio-product-description .eximio-reg-card:hover{ border-color:#9dbde4;box-shadow:0 6px 18px rgba(31,95,191,.08);transform:translateY(-1px) } .eximio-product-description .eximio-reg-kind{ display:inline-flex;margin:0 0 7px;padding:3px 7px;border-radius:999px;background:var(--eximio-blue-soft);color:var(--eximio-blue); font-size:10px;font-weight:750;letter-spacing:.04em;text-transform:uppercase } .eximio-product-description .eximio-reg-title{display:block;color:var(--eximio-blue-dark);font-size:14px;font-weight:700;line-height:1.35} .eximio-product-description .eximio-reg-scope{display:block;margin-top:5px;color:var(--eximio-muted);font-size:12px;line-height:1.5} .eximio-product-description .eximio-reg-source{display:block;margin-top:8px;color:var(--eximio-blue);font-size:11px;font-weight:650} @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{gap:6px;padding-bottom:8px} .eximio-product-description .eximio-flow-tab{min-height:38px;padding:8px 11px;font-size:12px} .eximio-product-description .eximio-flow-panel{padding:14px 12px} .eximio-product-description .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description .eximio-flow-timing{width:100%;max-width:none;margin-top:10px} .eximio-product-description .eximio-flow-panel .eximio-process-step{padding:30px 11px 12px} .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* Mobile flow timeline v3 *\/ @media(max-width:749px){ .eximio-product-description .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px; overflow:visible;padding:0 0 13px } .eximio-product-description .eximio-flow-tab-nav .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-flow-tab{ width:100%;min-height:44px;padding:8px 9px;border-radius:8px; white-space:normal;text-align:center;font-size:12px;line-height:1.3 } .eximio-product-description .eximio-flow-panels{margin-top:0} .eximio-product-description .eximio-flow-panel{ padding:0;border:0;border-radius:0;background:transparent } .eximio-product-description .eximio-flow-head{ display:block;margin:0 0 14px;padding:13px 12px; border:1px solid var(--eximio-line);border-radius:10px;background:#fff } .eximio-product-description .eximio-flow-head .eximio-route-title{ margin:0;color:var(--eximio-blue-dark);font-size:16px } .eximio-product-description .eximio-flow-timing{ width:100%;max-width:none;margin-top:10px;padding:9px 10px;border-radius:8px } .eximio-product-description .eximio-flow-timing strong{font-size:14px} .eximio-product-description .eximio-flow-panel .eximio-process{ position:relative;display:block;overflow:visible;margin:0;padding:0 0 0 34px } .eximio-product-description .eximio-flow-panel .eximio-process:before{ content:\"\";position:absolute;left:11px;top:17px;bottom:17px;width:2px; border-radius:2px;background:#c9daf0 } .eximio-product-description .eximio-flow-panel .eximio-process-step{ position:relative;display:block;width:100%;min-width:0;min-height:0; margin:0 0 11px;padding:12px 12px 12px 13px; border:1px solid #c9daf0;border-radius:9px;background:#fff; text-align:left;color:var(--eximio-blue-dark);font-size:13px;line-height:1.45 } .eximio-product-description .eximio-flow-panel .eximio-process-step:last-of-type{margin-bottom:0} .eximio-product-description .eximio-flow-panel .eximio-process-arrow{display:none} .eximio-product-description .eximio-step-number{ top:11px;left:-34px;min-width:24px;width:24px;height:24px;padding:0; border:2px solid #fff;border-radius:50%;background:var(--eximio-blue);color:#fff; font-size:10px;box-shadow:0 0 0 1px #b9cfea } .eximio-product-description .eximio-step-copy{display:block;font-weight:600} .eximio-product-description .eximio-step-time{ margin-top:7px;padding:4px 7px;border-radius:6px;font-size:10px } .eximio-product-description .eximio-flow-note{margin:11px 0 0;padding-left:34px} .eximio-product-description .eximio-timing-key{ margin-top:13px;padding:10px 11px;font-size:11px } .eximio-product-description .eximio-regulatory-grid{grid-template-columns:1fr} } \/* v4 topology-aware flow network: preserves branches, parallel workstreams and merge\/decision points *\/ .eximio-product-description .eximio-network{display:flex;flex-direction:column;align-items:stretch;gap:10px;margin-top:2px} .eximio-product-description .eximio-net-node{ position:relative;max-width:430px;margin:0 auto;padding:12px 14px;border:1px solid #c9daf0;border-radius:10px; background:var(--eximio-blue-soft);color:var(--eximio-blue-dark);font-size:13px;font-weight:650;line-height:1.42;text-align:center } .eximio-product-description .eximio-net-node--start{background:var(--eximio-blue);border-color:var(--eximio-blue);color:#fff;font-size:14px} .eximio-product-description .eximio-net-node--finish{background:#eaf6ee;border-color:#b8ddc4;color:#245b35} .eximio-product-description .eximio-net-node--alternative{background:#f8fafc;border-style:dashed;color:#475569} .eximio-product-description .eximio-net-node-sub{display:block;margin-top:4px;color:var(--eximio-muted);font-size:11px;font-weight:500} .eximio-product-description .eximio-net-time{ display:inline-flex;margin-top:7px;padding:3px 8px;border-radius:999px;background:#fff;color:var(--eximio-blue-dark); border:1px solid #c9daf0;font-size:10px;font-weight:750;line-height:1.2 } .eximio-product-description .eximio-net-node--start .eximio-net-time{color:var(--eximio-blue-dark)} .eximio-product-description .eximio-net-arrow{height:22px;display:flex;align-items:center;justify-content:center;color:#76a2d7;font-size:18px;font-weight:700;line-height:1} .eximio-product-description .eximio-net-arrow--major{height:26px;font-size:21px} .eximio-product-description .eximio-net-seq{display:flex;flex-direction:column;align-items:stretch} .eximio-product-description .eximio-net-seq\u003e.eximio-net-node{width:min(100%,430px)} .eximio-product-description .eximio-net-branch-group{ position:relative;margin:4px 0 8px;padding:16px 14px 14px;border:1px solid var(--eximio-line);border-radius:12px;background:#fbfdff } .eximio-product-description .eximio-net-group-label{ display:inline-flex;position:relative;margin:-29px 0 12px 4px;padding:4px 9px;border:1px solid #c9daf0;border-radius:999px; background:#fff;color:var(--eximio-blue);font-size:10px;font-weight:750;letter-spacing:.025em;line-height:1.25 } .eximio-product-description .eximio-net-branches{ display:grid;grid-template-columns:repeat(var(--eximio-branch-count),minmax(0,1fr));gap:12px;align-items:stretch } .eximio-product-description .eximio-net-branch{ min-width:0;padding:11px;border:1px solid #d6e2f1;border-radius:10px;background:#fff } .eximio-product-description .eximio-net-branch-head{display:flex;align-items:flex-start;gap:8px;margin:0 0 10px;padding-bottom:8px;border-bottom:1px solid #e6edf6} .eximio-product-description .eximio-net-branch-index{ flex:0 0 auto;display:inline-flex;align-items:center;justify-content:center;min-width:24px;height:20px;padding:0 5px;border-radius:999px; background:#e8f1fc;color:var(--eximio-blue);font-size:9px;font-weight:800;line-height:1 } .eximio-product-description .eximio-net-branch-title{color:var(--eximio-blue-dark);font-size:12px;font-weight:750;line-height:1.35} .eximio-product-description .eximio-net-branch-note{margin:-3px 0 9px;color:var(--eximio-muted);font-size:10px;line-height:1.4} .eximio-product-description .eximio-net-branch .eximio-net-node{width:100%;max-width:none;padding:10px 8px;font-size:11px} .eximio-product-description .eximio-net-branch .eximio-net-arrow{height:17px;font-size:14px} .eximio-product-description .eximio-net-junction{ width:min(100%,560px);margin:1px auto;padding:9px 12px;border:1px dashed #9dbde4;border-radius:9px;background:#f7fbff; color:var(--eximio-blue-dark);font-size:11px;font-weight:700;line-height:1.4;text-align:center } .eximio-product-description .eximio-net-junction--decision{border-style:solid;background:#eef5fd} .eximio-product-description .eximio-net-branch-group--decision .eximio-net-group-label{color:#475569;border-color:#cbd5e1} .eximio-product-description .eximio-net-branch-group--outputs{background:#f8fbff} @media(max-width:980px) and (min-width:750px){ .eximio-product-description .eximio-net-branches{grid-template-columns:repeat(2,minmax(0,1fr))} } @media(max-width:749px){ .eximio-product-description .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px;overflow:visible;padding:2px 0 9px } .eximio-product-description .eximio-flow-tab{ width:100%;min-width:0;min-height:42px;padding:8px 7px;border-radius:8px;white-space:normal;text-align:center;font-size:11px } .eximio-product-description .eximio-flow-tab:last-child:nth-child(odd){grid-column:1\/-1} .eximio-product-description .eximio-net-node{max-width:none;width:100%;padding:11px 10px;font-size:12px;text-align:left} .eximio-product-description .eximio-net-node--start{text-align:center} .eximio-product-description .eximio-net-branches{grid-template-columns:1fr;gap:9px} .eximio-product-description .eximio-net-branch-group{padding:15px 9px 10px;margin-top:8px} .eximio-product-description .eximio-net-group-label{ margin:-28px 0 10px 2px;max-width:calc(100% - 4px);white-space:normal;border-radius:7px;font-size:9px } .eximio-product-description .eximio-net-branch{padding:10px 9px} .eximio-product-description .eximio-net-branch-head{margin-bottom:8px} .eximio-product-description .eximio-net-branch-title{font-size:12px} .eximio-product-description .eximio-net-branch .eximio-net-node{ padding:9px 10px;border-left:3px solid #9dbde4;border-radius:7px;text-align:left;font-size:11px } .eximio-product-description .eximio-net-branch .eximio-net-node--finish{border-left-color:#8bc59c} .eximio-product-description .eximio-net-arrow{height:18px} .eximio-product-description .eximio-net-junction{width:100%;font-size:10px;text-align:left} } \/* v5 source-layout reconstruction: preserves the original diagram geometry while applying EXIMIO visual language *\/ .eximio-product-description--v6 .eximio-process-intro{max-width:980px} .eximio-product-description--v6 .eximio-flow-tab-nav{display:flex;flex-wrap:wrap;gap:8px;margin:16px 0 18px} .eximio-product-description--v6 .eximio-flow-tab{flex:0 1 auto;min-width:128px;padding:9px 13px;border:1px solid #cbdcf0;border-radius:8px;background:#fff;color:#315a82;font-size:12px;font-weight:650;line-height:1.35;text-align:center;cursor:pointer;transition:.15s ease} .eximio-product-description--v6 .eximio-flow-control{position:absolute!important;opacity:0!important;pointer-events:none!important} .eximio-product-description--v6 .eximio-flow-panel{display:none} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-tab-nav\u003elabel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-tab-nav\u003elabel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-tab-nav\u003elabel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-tab-nav\u003elabel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-tab-nav\u003elabel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-tab-nav\u003elabel:nth-child(6){background:#eaf2fc;border-color:#7fa7d7;color:#123e73;box-shadow:inset 0 0 0 1px #7fa7d7} .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(1):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(1), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(2):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(2), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(3):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(3), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(4):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(4), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(5):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(5), .eximio-product-description--v6 .eximio-flow-switcher\u003e.eximio-flow-control:nth-of-type(6):checked~.eximio-flow-panels\u003e.eximio-flow-panel:nth-child(6){display:block} .eximio-product-description--v6 .eximio-flow-panel{padding:18px;border:1px solid #dbe5f1;border-radius:12px;background:#fff} .eximio-product-description--v6 .eximio-flow-head{display:flex;gap:16px;align-items:flex-start;justify-content:space-between;margin-bottom:12px} .eximio-product-description--v6 .eximio-flow-timing{flex:0 0 auto;min-width:180px;padding:9px 11px;border:1px solid #d9e5f3;border-radius:8px;background:#f8fbff;text-align:right} .eximio-product-description--v6 .eximio-flow-timing span,.eximio-product-description--v6 .eximio-flow-timing small{display:block;color:#64748b;font-size:10px;line-height:1.35} .eximio-product-description--v6 .eximio-flow-timing strong{display:block;margin:2px 0;color:#123e73;font-size:13px;line-height:1.35} .eximio-product-description--v6 .eximio-map-scroll{width:100%;overflow-x:auto;overflow-y:hidden;padding:4px 0 8px;-webkit-overflow-scrolling:touch;scrollbar-width:thin} .eximio-product-description--v6 .eximio-map{position:relative;width:100%;aspect-ratio:var(--flow-ratio);min-height:420px;border:1px solid #e2eaf4;border-radius:12px;background:linear-gradient(180deg,#fbfdff 0%,#fff 100%);overflow:hidden} .eximio-product-description--v6 .eximio-map--dense{min-width:760px} .eximio-product-description--v6 .eximio-map-wire{position:absolute;z-index:1;background:#8eb3df;opacity:.88} .eximio-product-description--v6 .eximio-map-wire--v{width:1.5px;transform:translateX(-.75px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.5px;transform:translateY(-.75px)} .eximio-product-description--v6 .eximio-map-node{position:absolute;z-index:3;left:var(--x);top:var(--y);width:var(--nw,18%);transform:translate(-50%,-50%);padding:8px 9px;border:1px solid #bcd2ea;border-radius:10px;background:#f2f7fd;color:#234f78;font-size:11px;font-weight:650;line-height:1.28;text-align:center;box-shadow:0 2px 7px rgba(31,95,191,.06);overflow-wrap:anywhere} .eximio-product-description--v6 .eximio-map-node--start{background:#123e73;border-color:#123e73;color:#fff;font-size:12px} .eximio-product-description--v6 .eximio-map-node--finish{background:#eaf5f8;border-color:#8fc4d0;color:#174e5c} .eximio-product-description--v6 .eximio-map-node--decision{background:#fff;border:1.5px solid #1f5fbf;color:#123e73} .eximio-product-description--v6 .eximio-map-node--alternative{background:#fff;border:1px dashed #7d8ea2;color:#485a6d;font-size:10px} .eximio-product-description--v6 .eximio-map-node-sub{display:block;margin-top:3px;color:inherit;opacity:.72;font-size:9px;font-weight:500} .eximio-product-description--v6 .eximio-map-bracket:before,.eximio-product-description--v6 .eximio-map-bracket:after{content:\"\";position:absolute;right:-1px;width:9px;border-top:1px solid #8095aa} .eximio-product-description--v6 .eximio-map-note{position:absolute;z-index:4;transform:translate(-50%,-50%);padding:3px 7px;border-radius:999px;background:#fff;border:1px solid #d5e2f1;color:#61758b;font-size:9px;font-weight:650;line-height:1.25;white-space:nowrap} @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:7px} .eximio-product-description--v6 .eximio-flow-tab{min-width:0;padding:8px 7px;font-size:11px} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:10px} .eximio-product-description--v6 .eximio-flow-timing{min-width:0;margin-top:8px;text-align:left} .eximio-product-description--v6 .eximio-flow-panel{padding:10px} .eximio-product-description--v6 .eximio-map{min-height:390px} .eximio-product-description--v6 .eximio-map--dense{min-width:680px;min-height:500px} .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.24} .eximio-product-description--v6 .eximio-map-node--start{font-size:11px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:9px} .eximio-product-description--v6 .eximio-map-note{font-size:8px} } \/* V6 layout refinement: preserve original geometry, improve hierarchy and readability *\/ .eximio-product-description--v6 .eximio-flow-switcher{margin:14px 0 4px} .eximio-product-description--v6 .eximio-flow-tab-nav{ gap:5px;padding:5px;margin:0 0 12px;border:1px solid #e1eaf4;border-radius:12px; background:#f7fafe;scrollbar-width:thin } .eximio-product-description--v6 .eximio-flow-tab{ min-height:40px;padding:8px 13px;border-color:transparent;border-radius:8px;background:transparent; font-size:12.5px } .eximio-product-description--v6 .eximio-flow-tab:hover{border-color:#c6d9ef;background:#fff} .eximio-product-description--v6 .eximio-flow-panel{ padding:20px;border-color:#dce7f3;border-radius:14px;box-shadow:0 8px 24px rgba(18,62,115,.045) } .eximio-product-description--v6 .eximio-flow-head{ align-items:center;gap:24px;margin-bottom:18px;padding-bottom:15px } .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{ margin:0;font-size:19px;line-height:1.3 } .eximio-product-description--v6 .eximio-flow-timing{ flex:0 0 min(300px,40%);padding:9px 12px;border-radius:8px;background:#f5f9fe } .eximio-product-description--v6 .eximio-flow-timing span{ color:#64748b;font-size:10px;font-weight:750;letter-spacing:.045em;text-transform:uppercase } .eximio-product-description--v6 .eximio-flow-timing strong{margin-top:1px;font-size:14px} .eximio-product-description--v6 .eximio-flow-timing small{margin-top:2px;font-size:10px} .eximio-product-description--v6 .eximio-map-scroll{ position:relative;width:100%;padding:4px 0 8px;overflow-x:auto;overflow-y:hidden } .eximio-product-description--v6 .eximio-map{ width:100%;max-width:1160px;margin:0 auto;min-height:430px;border-color:#dde8f3;border-radius:14px; background:#fff; overflow:hidden;box-shadow:none } .eximio-product-description--v6 .eximio-map-wire{ background:#9ebbd9;opacity:.82;border-radius:999px } .eximio-product-description--v6 .eximio-map-wire--v{width:1.25px;transform:translateX(-.625px)} .eximio-product-description--v6 .eximio-map-wire--h{height:1.25px;transform:translateY(-.625px)} .eximio-product-description--v6 .eximio-map-node{ padding:9px 10px;border-color:#bdd2e8;border-radius:9px;background:#f4f8fd; color:#234f78;font-size:11.5px;line-height:1.32;font-weight:650; box-shadow:0 3px 10px rgba(18,62,115,.055) } .eximio-product-description--v6 .eximio-map-node--start{ padding-top:10px;padding-bottom:10px;background:#123e73;border-color:#123e73;color:#fff; font-size:12px;box-shadow:0 5px 14px rgba(18,62,115,.14) } .eximio-product-description--v6 .eximio-map-node--finish{ background:#edf8fa;border-color:#9ccbd4;color:#164d5a } .eximio-product-description--v6 .eximio-map-node--decision{ background:#fff;border:1.5px solid #3f79c2;color:#123e73;box-shadow:0 4px 12px rgba(31,95,191,.07) } .eximio-product-description--v6 .eximio-map-node--alternative{ background:#fff;border-color:#a7b5c5;color:#526274;font-size:10px;box-shadow:none } .eximio-product-description--v6 .eximio-map-node-sub{ margin-top:3px;font-size:9px;line-height:1.25;opacity:.7 } .eximio-product-description--v6 .eximio-map-note{ padding:3px 6px;border-color:#d4e1ee;background:rgba(255,255,255,.96);color:#60758a; font-size:8.5px;box-shadow:0 2px 6px rgba(18,62,115,.035) } @media(max-width:749px){ .eximio-product-description--v6 .eximio-flow-tab-nav{ display:grid;grid-template-columns:repeat(2,minmax(0,1fr));gap:5px;padding:5px;margin-bottom:10px } .eximio-product-description--v6 .eximio-flow-tab{min-height:38px;padding:7px 7px;font-size:11px;line-height:1.2} .eximio-product-description--v6 .eximio-flow-panel{padding:12px 10px;border-radius:12px;box-shadow:none} .eximio-product-description--v6 .eximio-flow-head{display:block;margin-bottom:12px;padding-bottom:12px} .eximio-product-description--v6 .eximio-flow-head .eximio-route-title{font-size:16px} .eximio-product-description--v6 .eximio-flow-timing{width:100%;max-width:none;margin-top:8px;padding:7px 9px} .eximio-product-description--v6 .eximio-flow-timing strong{font-size:13px} .eximio-product-description--v6 .eximio-map-scroll{ margin:0;padding:24px 0 10px;overscroll-behavior-x:contain;scroll-snap-type:x proximity } .eximio-product-description--v6 .eximio-map{ width:620px;min-width:620px;max-width:none;min-height:430px;margin-left:0;margin-right:0 } .eximio-product-description--v6 .eximio-map--dense{ width:820px;min-width:820px;min-height:510px } .eximio-product-description--v6 .eximio-map-node{padding:7px 7px;font-size:10px;line-height:1.25} .eximio-product-description--v6 .eximio-map-node--start{font-size:10.5px} .eximio-product-description--v6 .eximio-map-node--alternative{font-size:8.5px} .eximio-product-description--v6 .eximio-map-note{font-size:7.5px} } \u003c\/style\u003e \u003cdiv class=\"eximio-product-description eximio-product-description--v6\"\u003e \u003csection class=\"eximio-product-section eximio-product-overview\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eService Overview\u003c\/h2\u003e \u003cp\u003eEXIMIO supports medical device and IVD manufacturers preparing for market access in the Russian Federation through the current Roszdravnadzor national registration framework and, where appropriate, the Eurasian Economic Union (EAEU) registration route with Russia selected as the reference state. Support can cover pathway confirmation, classification, authorized-representative coordination, Russian-language dossier preparation, testing and evidence planning, submission support, authority questions and registration follow-up.\u003c\/p\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eProcess Flow \u0026amp; Timing\u003c\/h2\u003e \u003cp class=\"eximio-process-intro\"\u003eSelect the applicable pathway below. The final route depends on the device classification, intended purpose, evidence package and target market coverage.\u003c\/p\u003e \u003cdiv class=\"eximio-flow-switcher\"\u003e \u003cinput checked class=\"eximio-flow-control\" id=\"eximio-russia-flow-1\" name=\"eximio-russia-flow\" type=\"radio\"\u003e \u003cinput class=\"eximio-flow-control\" id=\"eximio-russia-flow-2\" name=\"eximio-russia-flow\" type=\"radio\"\u003e \u003cdiv aria-label=\"Registration pathway\" class=\"eximio-flow-tab-nav\" role=\"tablist\"\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-russia-flow-1\"\u003eRussia National Registration\u003c\/label\u003e \u003clabel class=\"eximio-flow-tab\" for=\"eximio-russia-flow-2\"\u003eEAEU Registration - Russia Reference State\u003c\/label\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panels\"\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eRussia National Registration\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eRoszdravnadzor statutory service time\u003c\/span\u003e \u003cstrong\u003e≤31 or ≤50 working days*\u003c\/strong\u003e \u003csmall\u003eRoute-dependent authority clock; testing, clinical-trial and applicant-response periods may be excluded.\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e \u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.88\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:4%;height:9%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:13%;height:6%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28%;top:19%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:19%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28%;top:19%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72%;top:19%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28%;top:27%;height:12%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72%;top:27%;height:12%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28%;top:39%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:39%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:39%;height:11%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:50%;height:11%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:61%;height:6%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28%;top:67%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:67%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28%;top:67%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72%;top:67%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28%;top:75%;height:10%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72%;top:75%;height:10%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:28%;top:85%;height:7%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:72%;top:85%;height:7%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:28%;top:92%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:92%;width:22%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:92%;height:5%\"\u003e\u003c\/span\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:23%\"\u003eRussia National Registration\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:22%\"\u003eRoute Confirmation \u0026amp; Risk Classification\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:27%;--nw:21%\"\u003eRussian Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:27%;--nw:24%\"\u003eTechnical \/ Operational Documentation \u0026amp; Russian Localization\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:39%;--nw:24%\"\u003eTesting, Safety \u0026amp; Clinical Evidence Package\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:50%;--nw:23%\"\u003eCompile \u0026amp; Submit Registration Dossier\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:50%;--y:61%;--nw:26%\"\u003eHuman-Participant Clinical Trial Requiring Authority Permission?\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:28%;--y:75%;--nw:19%\"\u003eNo\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--alternative\" style=\"--x:72%;--y:75%;--nw:19%\"\u003eYes\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:28%;--y:85%;--nw:23%\"\u003eRoszdravnadzor Quality \/ Safety \/ Efficacy Expertise\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:72%;--y:85%;--nw:24%\"\u003eClinical Trial Permission, Trial \u0026amp; Final Expertise\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:97%;--nw:25%\"\u003eRegistration Decision \u0026amp; State Registry Entry\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-flow-panel\"\u003e \u003cdiv class=\"eximio-flow-head\"\u003e \u003ch3 class=\"eximio-route-title\"\u003eEAEU Registration - Russia as Reference State\u003c\/h3\u003e \u003cdiv class=\"eximio-flow-timing\"\u003e \u003cspan\u003eEAEU statutory stage clocks\u003c\/span\u003e \u003cstrong\u003e45 working days to expert opinion*\u003c\/strong\u003e \u003csmall\u003eProduction inspection may take up to 90 working days; recognition-state and applicant-response periods are additional.\u003c\/small\u003e \u003c\/div\u003e \u003c\/div\u003e \u003cdiv class=\"eximio-map-scroll\"\u003e \u003cdiv class=\"eximio-map eximio-map--dense\" style=\"--flow-ratio:0.90\"\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:4%;height:9%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:13%;height:6%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27%;top:19%;width:23%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:19%;width:23%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27%;top:19%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:73%;top:19%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:27%;top:27%;height:12%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:73%;top:27%;height:12%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:27%;top:39%;width:23%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:39%;width:23%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:39%;height:11%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:50%;height:11%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:61%;height:10%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:71%;height:8%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:29%;top:79%;width:21%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:79%;width:21%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:29%;top:79%;height:9%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:71%;top:79%;height:9%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:29%;top:88%;height:5%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:71%;top:88%;height:5%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:29%;top:93%;width:21%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--h\" style=\"left:50%;top:93%;width:21%\"\u003e\u003c\/span\u003e \u003cspan class=\"eximio-map-wire eximio-map-wire--v\" style=\"left:50%;top:93%;height:5%\"\u003e\u003c\/span\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--start\" style=\"--x:50%;--y:4%;--nw:29%\"\u003eEAEU Registration - Russia as Reference State\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:13%;--nw:26%\"\u003eSelect Reference State \u0026amp; Recognition State(s)\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:27%;--y:27%;--nw:22%\"\u003eEAEU Authorized Representative\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:73%;--y:27%;--nw:24%\"\u003eClassification, Nomenclature \u0026amp; Evidence Strategy\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:39%;--nw:27%\"\u003eTesting \u0026amp; Registration Dossier under Decision No. 46\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:50%;--nw:28%\"\u003eSubmit Registration \u0026amp; Examination Applications to Roszdravnadzor\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:61%;--nw:23%\"\u003eCompleteness Review \u0026amp; Procedure Start\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:50%;--y:71%;--nw:23%\"\u003eReference-State Examination\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--decision\" style=\"--x:50%;--y:79%;--nw:23%\"\u003eProduction Inspection Required?\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:29%;--y:88%;--nw:21%\"\u003eNo - Expert Opinion\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--step\" style=\"--x:71%;--y:88%;--nw:24%\"\u003eYes - Production Inspection \u0026amp; Expert Opinion\u003c\/div\u003e \u003cdiv class=\"eximio-map-node eximio-map-node--finish\" style=\"--x:50%;--y:98%;--nw:29%\"\u003eRecognition-State Agreement, Registration Decision \u0026amp; EAEU Register\u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/div\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRegulatory Basis \u0026amp; Official References\u003c\/h2\u003e \u003cp\u003eThe links below point to official Russian or EAEU regulatory sources. Applicable requirements should be reconfirmed at project start because implementing rules and transition measures may be updated.\u003c\/p\u003e \u003cdiv class=\"eximio-regulatory-grid\"\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/publication.pravo.gov.ru\/document\/0001202411300042\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e \u003cspan class=\"eximio-reg-kind\"\u003eLaw\u003c\/span\u003e \u003cspan class=\"eximio-reg-title\"\u003eGovernment Resolution No. 1684 of 30 Nov 2024\u003c\/span\u003e \u003cspan class=\"eximio-reg-scope\"\u003eCurrent Rules for State Registration of Medical Devices in the Russian Federation.\u003c\/span\u003e \u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e \u003c\/a\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/roszdravnadzor.gov.ru\/medproducts\/registration\/registration\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e \u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e \u003cspan class=\"eximio-reg-title\"\u003eRoszdravnadzor - State Registration of Medical Devices\u003c\/span\u003e \u003cspan class=\"eximio-reg-scope\"\u003eCurrent filing routes, document requirements, service-time information and applicant notices.\u003c\/span\u003e \u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e \u003c\/a\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/eec.eaeunion.org\/en\/comission\/department\/deptexreg\/ls1\/MD_acts.php\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e \u003cspan class=\"eximio-reg-kind\"\u003eEAEU Law Library\u003c\/span\u003e \u003cspan class=\"eximio-reg-title\"\u003eEEC Acts in the Sphere of Medical Device Circulation\u003c\/span\u003e \u003cspan class=\"eximio-reg-scope\"\u003eOfficial EAEU index including Decision No. 46 and related rules for registration, safety, testing and clinical evaluation.\u003c\/span\u003e \u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e \u003c\/a\u003e \u003ca class=\"eximio-reg-card\" href=\"https:\/\/roszdravnadzor.gov.ru\/medproducts\/registrationEAEU\" rel=\"noopener noreferrer\" target=\"_blank\"\u003e \u003cspan class=\"eximio-reg-kind\"\u003eOfficial Guidance\u003c\/span\u003e \u003cspan class=\"eximio-reg-title\"\u003eRoszdravnadzor - EAEU Medical Device Registration\u003c\/span\u003e \u003cspan class=\"eximio-reg-scope\"\u003eRussia-specific EAEU filing information, current notices, services and applicant guidance.\u003c\/span\u003e \u003cspan class=\"eximio-reg-source\"\u003eOpen official source ↗\u003c\/span\u003e \u003c\/a\u003e \u003c\/div\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eRelated Regulatory Support\u003c\/h2\u003e \u003cp\u003eAuthorized-representative coordination, route and classification review, Russian-language dossier adaptation, technical and clinical evidence planning, laboratory and testing coordination, production-inspection preparation, authority-response support and registration-certificate maintenance can be included according to the project scope.\u003c\/p\u003e \u003c\/section\u003e \u003csection class=\"eximio-product-section\"\u003e \u003ch2 class=\"eximio-product-heading\"\u003eEXIMIO Support\u003c\/h2\u003e \u003cp\u003eContact EXIMIO BIOTEC for pathway confirmation, document-gap review, testing and submission planning, regulatory dossier preparation, Roszdravnadzor \/ EAEU coordination support and a project-specific quotation.\u003c\/p\u003e \u003c\/section\u003e \u003c\/div\u003e","brand":"EXIMIO BIOTEC","offers":[{"title":"Russia National Registration","offer_id":47485028728988,"sku":"REG-RU-NATIONAL","price":0.0,"currency_code":"CNY","in_stock":true},{"title":"EAEU Registration - Russia Reference State","offer_id":47485028761756,"sku":"REG-RU-EAEU","price":0.0,"currency_code":"CNY","in_stock":true}]}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0763\/8784\/4252\/collections\/ChatGPT_Image_2026_8_26_10_58_09_2_e3adeb04-8573-496f-83de-1d67dd108c1d.png?v=1787733593","url":"https:\/\/exmbio.com\/collections\/registration.oembed","provider":"EXIMIO BIOTEC","version":"1.0","type":"link"}