Medical Device Registration in Russia and EAEU
Classification, registration strategy, technical & operational documentation, testing, dossier submission and Roszdravnadzor support.
Six Registration Phases
Classification & Registration Strategy
Risk class, nomenclature code, role structure — registration certificate holder, manufacturer, production site (can be different legal entities), route selection (Russia/EAEU), testing plan and timeline
Technical Documentation
TD, TU, passport, technical file in the format accepted by labs and experts
Operational Documentation
Instructions for use, labelling, packaging — error-free from the start
Testing
Technical, toxicological, clinical: programme, laboratories, support
Dossier & Submission
Registration dossier assembly, Roszdravnadzor submission, procedure management, query responses
Post-Registration
Amendments, line extensions, registration maintenance, post-market surveillance
Registration Routes
3–6 months
Notification procedure. Minimal testing, simplified documentation.
6–12 months
Expert procedure. Clinical data or equivalence evidence, full dossier.
12–18 months
Full expert review with clinical investigations. Maximum requirements.
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