Eurasian Countries Agree to Harmonized Medical Device Framework
An agreement to establish a harmonized regulatory system for medical devices across Russia and several former Soviet bloc countries has been signed, but few details have thus far been released.
Signatories to the Eurasian Economic Union Agreement include Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia.
Although no governments involved in the proposal have yet released guidance, implementation efforts are expected to last until 2021. Additional details on local-level implementation plans are anticipated for March 2016.
According to Emergo consultants and third-party sources in Russia, medical device manufacturers will have the option of registering their products for all five countries via the Eurasian framework or with individual countries’ market regulators such as Roszdravnadzor in Russia. For firms opting to seek approval through the Eurasian system, registration in one market will be accepted by regulators in all other participating markets.
The agreement does not preclude participating governments implementing their own national medical device regulatory requirements, however. Futhermore, Russia continues to prove one of the world’s most challenging and opaque medical device markets, so further details on how or if the new Eurasian registration framework would ease market entry requirements in the region are needed.