Medical device license holder

According to Russian legislation manufacturer could be the holder of registration certificate even if manufacturer is a foreign entity.

Otherwise Authorized Representative company could be only Russian entity and each registration certificate has AR (AR is not listed in registration certificate, it is listed in registration dossier which Roszdravnadzor keeps in archive). AR company is in charge of medical devices circulation inside Russia and it should be appointed upon initial submission of registration dossier to Roszdravnadzor. Such AR company should reply Roszravnadzor inquiries and handle all arose adverse events. Information about Government control – here, analytics – by link.

For manufacturers who has no representative office in Russia and use distributor(s) BW team recommends to appoint third party as AR company.