By Stewart Eisenhart, Emergo Group
Medical device registrations in Russia remain on hold as the government reorganizes the registration division* of its device regulatory agency Roszdravnadzor.
According to Russian news sources*, Roszdravnadzor ‘s registration office has been temporarily closed as authorities investigate allegations of bribery among senior officials. The government plans to assemble a new team of personnel for the Roszdravnadzor registration division, and also intends to review all medical device Registration Certificates previously issued by the agency.
Although the investigation into Roszdravnadzor has put medical device registration in Russia on hold for the time being, a reorganization of the agency may ultimately create a more transparent and predictable approval process.
*Please note: All reference articles above link to documents in Russian only. Use Google Translate to read this content in other languages.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.