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.
Choose an option
Service Overview
EXIMIO 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.
Process Flow & Timing
Select the applicable pathway below. The final route depends on the device classification, intended purpose, evidence package and target market coverage.
Russia National Registration
Roszdravnadzor statutory service time ≤31 or ≤50 working days* Route-dependent authority clock; testing, clinical-trial and applicant-response periods may be excluded.
Russia National Registration
Route Confirmation & Risk Classification
Russian Authorized Representative
Technical / Operational Documentation & Russian Localization
Testing, Safety & Clinical Evidence Package
Compile & Submit Registration Dossier
Human-Participant Clinical Trial Requiring Authority Permission?
No
Yes
Roszdravnadzor Quality / Safety / Efficacy Expertise
Clinical Trial Permission, Trial & Final Expertise
Registration Decision & State Registry Entry
EAEU Registration - Russia as Reference State
EAEU statutory stage clocks 45 working days to expert opinion* Production inspection may take up to 90 working days; recognition-state and applicant-response periods are additional.
EAEU Registration - Russia as Reference State
Select Reference State & Recognition State(s)
EAEU Authorized Representative
Classification, Nomenclature & Evidence Strategy
Testing & Registration Dossier under Decision No. 46
Submit Registration & Examination Applications to Roszdravnadzor
Completeness Review & Procedure Start
Reference-State Examination
Production Inspection Required?
No - Expert Opinion
Yes - Production Inspection & Expert Opinion
Recognition-State Agreement, Registration Decision & EAEU Register
Regulatory Basis & Official References
The 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.
Law Government Resolution No. 1684 of 30 Nov 2024 Current Rules for State Registration of Medical Devices in the Russian Federation. Open official source ↗ Official Guidance Roszdravnadzor - State Registration of Medical Devices Current filing routes, document requirements, service-time information and applicant notices. Open official source ↗ EAEU Law Library EEC Acts in the Sphere of Medical Device Circulation Official EAEU index including Decision No. 46 and related rules for registration, safety, testing and clinical evaluation. Open official source ↗ Official Guidance Roszdravnadzor - EAEU Medical Device Registration Russia-specific EAEU filing information, current notices, services and applicant guidance. Open official source ↗
Related Regulatory Support
Authorized-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.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, testing and submission planning, regulatory dossier preparation, Roszdravnadzor / EAEU coordination support and a project-specific quotation.