FAQ about medical device market approval
Real questions from our experience.
| FAQ – general questions about market access:
- What is required to start sales of medical device inside Russia?
- Should foreign manufacturer have Russian entity to join Russian market?
- Should foreign manufacturer have sales partner to start market access process?
- Does Russia have special regulation for medical devices?
- If I have borderline product, how to be sure that this is medical device (or not)?
- State registration for medical devices (about medical device registration in Russia – main information),
- Other approvals for medical devices, except of state registration – GOST R, EAEU regulation (custom union regulation – CU TR), special licensing.
- Who is license holder (for state registration and for GOST R)?
- What happened after registration process and when I should update certificate or registration dossier?
| FAQ about market approval:
- How to do documents legalization?
- Which devices are measuring medical devices and why this is important?
- About medical device registration with drug (Sept 2017 update).
- About testing process inside Russia – How testing should be provided according to 2n and how it looks like by fact.
- Classification review – Order of Russian Government 4n.
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