Russia to Release New Medical Device Regulations

Russia is expected to release new medical device regulations within the next few weeks, writes Stewart Eisenhart, an editor covering regulatory affairs for Emergo Group, in a blog post on the Massdevice website. Eisenhart expects the regulations to be clearer and have more specific requirements than current regulations, for example by providing reporting timelines and requirements for post-approval reporting. One part of the new regulations is expected to cover the clinical trial process, with components such as requirements for ethics committee reviews and patient agreements, Eisenhart writes.

The new regulatory requirements are part of Russia’s plan to become a major player on the medical device market. EMDT Editor in Chief Norbert Sparrow met with Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, in Düsseldorf last November. Tsyb mentioned that the country wants to streamline regulatory requirements in order to make it easier for Russian medical device manufacturers to export their products. The government recently approved a €4.5 billion investment programme in the medtech and pharmaceutical industries. Whether the regulations will make it easier for foreign companies operating in Russia to navigate the regulatory system remains to be seen.

Tags: device regulations, Russia