{"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; 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-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}],"url":"https:\/\/exmbio.com\/products\/health-canada-medical-device-registration-service","provider":"EXIMIO BIOTEC","version":"1.0","type":"link"}