New Medical Device Regulations Imminent in Russia

Update 02/07/2012: We have been informed by our Moscow office that Russian authorities have postponed implementation of these regulations until June 2012.

Russian authorities are expected to implement new medical device regulations concerning authorized representation, vigilance, country-of-origin approval and other issues within the next several weeks.

According to Emergo Group’s Moscow office, Roszdravnadzor and the Russian Ministry of Public Health are still negotiating aspects of the new regulations pertaining to clinical studies. But the new rules are anticipated to include the following components:

• Authorized Representation may be required and if so, the Authorized Representative role in Russia will resemble the European arrangement, and will serve as the liaison between manufacturers and Roszdravnadzor for all vigilance-related activities. (It remains unclear whether this requirement will actually go into effect.)
• Medical device vigilance requirements have been more clearly defined and delineated. Reporting timelines and post-approval reporting to Roszdravnadzor are expected to be part of these new requirements.
• Home country approval will be required across the board.
• Products classified as measuring devices will require additional certification. This requirement will also be retroactive, and will likely affect devices such as blood pressure monitors.
• Russia’s clinical trial process will become more formalized, requiring protocols, ethics committee reviews and patient agreements.

Once enacted, these new rules will significantly impact the Russian medical device registration process. We will provide updates as soon as we receive further details.