post-bg-545
calendary May 30, 2023

Documents confirming the registration of a medical device in the country of origin are not required for registration of a medical device in Russia

Regarding the national registration of medical devices in the Russian Federation, it is often clarified - is registration required in the country of origin or is a CE certificate, declaration, Free Sale certificate, export certificate and other such documents required? According to the current position of the Federal Service of Roszdravnadzor (the relevant reply to our request was received in April 2023), such documents are optional, that is, registration of a medical device in the Russian Federation is possible even without their presence or submission. This can be convenient, for example, if your medical device is going through the registration process in the country of origin. Thus, you will be able to apply  documents for registration of a medical device in the Russian Federation simultaneously with registration in the country of origin.

The request submitted by the Company BW and the reply from the regulatory authority (Roszdravnadzor) are in the attached files (in Russian).

References:
  1. Request-BW-13.04.2023
  2. The reply from the regulatory authority (Roszdravnadzor) 13.04.2023

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