Russia does not currently have bilateral mutual recognition agreements with the EU or the U.S.. Further the necessary tests should be performed in Russia. Russia’s regulatory requirements are available only in the Russian language. Submission of registration documentation and communications with the country’s responsible authority Federal Service for Surveillance in Healthcare (also known as the Roszdravnadzor) are conducted also almost exclusively in Russian. Moreover it is important to know that all manufacturers based outside of Russia will need to designate a local representative.
Prior to submission of the technical file to the authority, the applicant should perform different technical (mechanical, electrical, EMV) and toxicological (biocompatibility) tests according to the applicable GOST—R standards in Russian test laboratories. The compiled technical file should be submitted to the authority, which in turn delegates the expertise of technical documents and test results to a safety experts' organisation. Based on the review result of the safety experts' organisation, the extent of clinical evaluation is defined.
The last step of registration is the evaluation of the clinical test results and the issue of the registration certificate. The certificate is valid for an indefinite period of time.
After the registration, a local 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. 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.