All medical devices must be submitted to the main Russian Medical Device Agency, the Federal Service on Surveillance In Healthcare, more commonly known as «Roszdravnadzor» before being imported, sold, and used in Russian Federation.
Unlike most countries, Russia still relies on product testing in granting approval for medical devices, and this testing must be completed regardless of whether the device already has US 510(k) clearance or European CE Marking.
Russian medical device classification
Medical devices in Russia are classified in much the same manner as Europe: Class 1, 2a, 2b and 3.
We can assist you with medical device registration services for Russia:
- Advise on classification and family grouping of your devices in the Russian Federation.
- Prepare registration files according to Russian regulations.
- Facilitate all trials (technical, toxicology and so on) necessary for registration of your device.
- Coordinate translation of the files of the registration dossier and other technical documents into Russian.
- Coordinate application submission to Roszdravnadzor within the Ministry of Health.
- Coordinate testing, application and registration fees.
- Assistance obtaining Declaration of Conformity Certification (formerly referred to as GOST-R Certificate of Conformity) from Gosstandart.
Medical device approval and certification process in Russian Federation:
The department of the Roszdravnadzor reviews applications and decides on accepting the documents for registration. Afterwards it defines which tests (usually technical, clinical and toxicological tests) of the medical device have to be performed in accredited clinical centers and test laboratories.
The last step of registration is the evaluation of the test results and the issue of the registration certificate. The certificate is valid for an indefinite period of time.
It is important to note that medical devices can only be imported into Russia by the holder of the certificate of registration. Therefore, all manufacturers based outside of Russia will need to designate a local representative.
After the registration, a Russian representative must obtain a declaration of conformity, verifying the product’s compliance with the technical requirements of the applicable GOST standards.
The Declaration of Conformity has recently replaced the GOST-R Certificate for most medical devices, although the underlying technical requirements remain the same. The Declaration of Conformity is valid for a period of up to three years.
Once a Certificate of Registration and a Declaration of Conformity have been issued, the medical device can be imported into Russia and legally placed on the market for sale.