Registration of medical devices is a prerequisite for their import, use, sale, and production on the territory of the Russian Federation

Any tools, devices, appliances, equipment, materials and other medical products are subject to mandatory State registration.

The FDA, CE and certificates of other countries are not valid in Russia.

Registration of a medical device

Registration of a medical device
Changes to the registration certificate / dossier (VIRU / VIRD)
Checking packages of documents
Obtaining a permit to import a medical device
Preparation of documents

Accompanying tests

Toxicological tests
Clinical trials

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General scheme to obtain a registration certificate in Russia

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