REGULATORY & MARKET ACCESS

Medical Device & IVD Registration Support

EXIMIO supports medical device and IVD manufacturers with regulatory pathway assessment, documentation, submission coordination and registration support across major international markets.

Product Country Description
Russia / EAEU Medical Device Registration Service
Russia / EAEU Medical Device Registration Service
Regulatory support for medical device and IVD market access in Russia, covering Roszdravnadzor national registration and the EAEU registration pathway with Russia as the reference state. EXIMIO can support pathway confirmation, dossier localization, testing coordination, submission preparation and authority follow-up.
U.S. FDA UDI Application Service
U.S. FDA UDI Application Service
Support for UDI preparation, identifier creation and GUDID-related data submission for medical devices entering the U.S. market. The service can include identifier-system setup, device data organization and database-entry support.
U.S. FDA Premarket Submission & Regulatory Strategy
U.S. FDA Premarket Submission & Regulatory Strategy
Regulatory support for U.S. FDA pathways including Pre-Submission, 513(g), 510(k), De Novo and Modular PMA. EXIMIO can support pathway planning, dossier preparation, submission coordination and review follow-up.
Australia TGA Medical Device Registration Service
Australia TGA Medical Device Registration Service
Support for Australian medical-device market access, from product classification and conformity evidence to TGA submission and ARTG inclusion. The service can be scoped for Class I through higher-risk devices and special-material categories.
UK MHRA IVD Registration Service
UK MHRA IVD Registration Service
UK market-access support for IVD products, combining the source List A/List B and General/Self-test workflows into one product. EXIMIO can assist with classification, conformity-route planning, technical documentation and MHRA-related registration coordination.
Brazil ANVISA Medical Device Registration Service
Brazil ANVISA Medical Device Registration Service
Support for medical-device market access in Brazil across Class I–IV pathways, including classification, local compliance evidence and ANVISA submission coordination. Requirements are scoped according to device class and applicable certification or quality-system obligations.
EU IVDR CE Registration Service
EU IVDR CE Registration Service
EU IVDR market-access support for Class A–D in vitro diagnostic devices, including conformity-route planning, technical documentation, QMS coordination and notified-body interaction where required. Routes are organized by risk class and conformity-assessment approach.
Health Canada Medical Device Registration Service
Health Canada Medical Device Registration Service
Registration support for Class I–IV medical devices entering Canada, including MDEL/MDL pathway coordination and MDSAP-related preparation where applicable. Service scope is matched to the device risk class and manufacturer role.
U.S. FDA Establishment Registration & Device Listing Service
U.S. FDA Establishment Registration & Device Listing Service
Support for FDA establishment registration and medical-device listing, including standard listing and 510(k)-exempt routes. EXIMIO can coordinate classification checks, account setup, U.S. agent information and listing submission steps.
START A REGISTRATION PROJECT

Planning Market Access for Your Medical Device or IVD?

Tell us your target market, product type, intended use and current regulatory status. Our team can help identify the applicable pathway and discuss a registration approach based on your project.

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