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Registration requirements for medical devices in Russia

Russia has not yet signed bilateral mutual recognition agreements with the European Union or the United States, and the necessary tests need to be carried out in Russia. Russian regulations require only a Russian version. In Russia, registration documents can only be submitted and communicated with the Federal Service for Health Supervision (Roszdravnadzor), the national healthcare regulatory agency of Russia. Also know that all manufacturers outside Russia need to appoint a local representative.

Russian medical device registration process

The Ministry of Health and Social Development of the Russian Federation examines all applications and decides whether to accept registration documents. The department will then dictate which additional tests the medical device should undergo at accredited clinical centers and testing laboratories. Finally, the clinical test results are evaluated and a certificate of registration is issued. There is no fixed period of validity for the certificate. After registration, the Russian representative must make a compliance statement to verify that the product meets the technical requirements of the application of the Russian Compulsory Certification Certificate (GOST-R) standard. For many medical devices, compliance statements have now replaced mandatory Certification in Russia. Compliance statements can be valid for up to three years. Once a certificate of registration and a statement of compliance have been issued, medical devices can be imported into Russia and legally sold on the market.

Registration requirements for medical devices in Russia

Russian medical device registration process

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