What does the registration procedure for a medical device in Russia include?

For the circulation of medical devices in Russia, it is necessary to issue a Registration Certificate. A Registration Certificate for a medical item is a document confirming the fact of the of a medical device’s state registration. The Federal Service for Surveillance in Healthcare (Roszdravnadzor) performs State registration of medical products. Registration of medical products is a State procedure, the purpose of which is to allow the release of high-quality and safe products to the Russian market. Let us inform you about the registration procedure of the Registration Certificate in Russia.

The registration procedure for a medical device includes documents preparation, technical tests, toxicological studies, clinical trials, examination of the quality, effectiveness and safety of medical devices, their state registration, import into the Russian Federation. Let us explain each stage in detail.

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