Sep 6, 2013
Russian medical device market regulator Roszdravnadzor has begun providing updates that suggest greater alignment and harmonization with other countries’ rules and requirements. So far no concrete proposals have emerged, however.
According to a new Roszdravnadzor announcement, Russian regulators have begun a new effort to simplify some medical device registration procedures as well as ease re-registration requirements for devices already sold on the Russian market. The announcement includes the following news:
More generally, Roszdravnadzor officials have cited goals of boosting availability of safe and effective medical devices to the Russian population, and of harmonizing the Russian medical device regulatory system with those of developed markets. A less opaque, simplified registration process would significantly boost foreign manufacturers’ interest in this massive and diverse market. Hopefully Roszdravnadzor’s stated goals translate into actual policies regarding medical device registration in Russia sooner rather than later.
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.
Medical device market regulators in Russia have begun developing guidelines for evaluating quality, safety and effectiveness of in vitro diagnostic (IVD) devices.
Roszdravnadzor officials have started consultations with industry and academic sources in order to draw up uniform standards for IVD product reviews.