By Stewart Eisenhart, Emergo Group
Russian medical device regulators have decided to extend their deadline for requiring medical device manufacturers to obtain replacement registration certifications (links to webpage in Russian) from January 2014 to January 2017.
At a July 15 meeting of Russian medical device market regulator Roszdravnadzor and the Russian Ministry of Health, officials agreed to propose amending Government Decision number 1416 in order to allow the deadline extension as well as make registration requirements for low-risk medical devices less complex.
Earlier in 2013, Roszdravnadzor announced new requirements that any medical device registered in Russia without a specific validity date would have to be re-registered by January 2014. Pushing the re-registration deadline back three years will allow affected manufacturers more breathing room to comply with new Russian medical device registration requirements.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
