By Stewart Eisenhart, Emergo Group

Medical device market regulators in Russia have begun developing guidelines (link in Russian) 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. 

Final guidelines will be posted online by Roszdravnadzor after final sign-off by the Russian Ministry of Health. No specific timelines are yet available.

This marks the second announcement in recent days regarding medical device and IVD regulatory changes planned or underway in the Russian market. Emergo Group will provide further details on regulatory developments in Russia as we learn them.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.