May 6, 2013
Medical device registrations in Russia remain on hold as the government reorganizes the registration division of its device regulatory agency Roszdravnadzor.
According to medical device Registration Certificates previously issued by the agency.
Although the investigation into Roszdravnadzor has put medical device registration in Russia on hold for the time being, a reorganization of the agency may ultimately create a more transparent and predictable approval process.
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.
On 7 March 2013, the Head of the Federal Service for Surveillance in Healthcare, commonly known as Roszdravnadzor, retired from her position. Mrs Elena Telnova is replaced by Mr. Milhail Murashko. Mr. Murashko previously has worked for the Ministry of Health of the Russian Federation. Roszdravnadzor is the Russian authority that is responsible for the registration and surveillance of medical devices.
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.