Jan 25, 2012
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:
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.
Revised regulations for the Russian medical device market have been in effect since January 1, 2013, and Emergo Group has now learned more details of these changes, although some specifics of the new rules are still needed.
All medical device registrations submitted to Russian medical device market regulator Roszdravnadzor after January 1, 2013 will fall under the new requirements; applicants seeking registration under the previous regulations must provide a written statement to Roszdravnadzor as soon as possible.
The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling. Also under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues. All orders under consideration must be approved before authorities begin implementing actual regulations.