Jan 9, 2013
Russian regulators have reportedly published long-awaited changes to the country's regulatory process for medical devices.
The revised regulations took effect January 1, 2013, according to Russian medical device regulator Rozsdravnadzor. Emergo has been anticipating announcement of these changes, and will provide a more detailed evaluation of these requirements following thorough analysis. We will keep you posted of further details as we learn them.
Among possible changes to Russian medical device regulations previously reported by Emergo are new testing sample import permit, expert device review and clinical testing requirements.
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.