Russia does not currently have bilateral mutual recognition agreements with the EU or the U.S.. Further, Russia’s regulatory requirements are available only in the Russian language, and communications with the country’s Federal Service on Surveillance in Healthcare and Social Development (also known as the Roszdravnadzor) are conducted almost exclusively in Russian.
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 additionally performed in accredited clinical centres 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-R 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.
TÜV SÜD technical professionals have first-hand knowledge of the technical and regulatory requirements for entry into the Russian market, as well as extensive experience in achieving approval of medical devices for sale in Russia.