Russia Market Access for Medical Device

REGULATORY AGENCY

• Federal Service on Surveillance in Healthcare (Roszdravnadzor)*

*All registration certificates with unlimited validity and were issued before 31 December 2012 must be re-issued. The previous deadline for re-issuing of the existing registration certificates with unlimited validity has been cancelled by Roszdravnadzor and extended to January 2021.

REGULATIONS

• Approval of medical devices is mandatory in the Russian Federation. Manufacturers or distributors must obtain registration for their medical devices before they can place them on the Russian market.
• In the first and most important step, medical devices are registered by Roszdravnadzor. In this step, the devices generally undergo technical testing for safety and biocompatibility, and also clinical testing in accredited Russian hospitals.
• In the second step, a Declaration of Conformity issued by an accredited certification body must be obtained for the medical device. This declaration can only be issued in the name of a distributor located in the Russian Federation.
• Products must be marked with the GOST-R Mark.

GUIDELINES

• A local representative is usually required.
• Devices must be tested to Russian standards regardless of whether the product has already achieved US 510(K), EU CE Marking or other national approvals
• A registration certificate will be issued upon submission of a satisfactory registration dossier. 
• Device classification is similar to that applied in Europe. 

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