Possible Thaw in Russian Medical Device Regulations?

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:

• New registration certification requirements for devices approved by Roszdravnadzor prior to January 1 2013 have been postponed until January 1 2017
• Clinical trial reports obtained before January 1 2013 for device registration renewals will be accepted by Roszdravnadzor through 2014
• A new electronic submission system for medical device registration is currently in development

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. 

Stewart Eisenhart