Medical Device Product Registration and Approval in Russia
MEDICAL DEVICE REGULATION IN RUSSIA
Medical devices are regulated by the Federal Service for Surveillance in Healthcare (Roszdravnadzor) from the Ministry of Health whose objective is to ensure that only quality and safe medical devices are introduced into the Russian market. Medical devices are regulated under the Decree of the Government of the Russian Federation No. 1416.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN RUSSIA
Medical devices are classified into 4 categories namely class I, IIa, IIb and III (I being the lowest risk and III being the highest risk).
Testing in accredited labs in Russia along with technical information submission is required in order to get the registration certificate. The local representative also needs to attain a Declaration of Conformity certification before the device can be imported.