FAQ about medical device market approval

Real questions from our experience.

| FAQ  – general questions about market access:

  1. What is required to start sales of medical device inside Russia?
  2. Should foreign manufacturer have Russian entity to join Russian market?
  3. Should foreign manufacturer have sales partner to start market access process?
  4. Does Russia have special regulation for medical devices?
  5. If I have borderline product, how to be sure that this is medical device (or not)?
  6. State registration for medical devices (about medical device registration in Russia – main information),
  7. Other approvals for medical devices, except of state registration – GOST R, EAEU regulation (custom union regulation – CU TR), special licensing.
  8. Who is license holder (for state registration and for GOST R)?
  9. What happened after registration process and when I should update certificate or registration dossier?

| FAQ about market approval:

  1. How to do documents legalization?
  2. Which devices are measuring medical devices and why this is important?
  3. About medical device registration with drug (Sept 2017 update).
  4. About testing process inside Russia – How testing should be provided according to 2n and how it looks like by fact.
  5. Classification review – Order of Russian Government 4n.


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