State re-registration of medical devices in Belarus
Re–registration of medical devices is a procedure for confirming the quality, safety and effectiveness of medical devices and medical equipment for compliance with current norms and standards, in order to permit import and release into circulation on the territory of the Republic of Belarus
In which cases are medical devices subject to state registration?
The re–registration of medical devices is regulated by the Law of the Republic of Belarus of 18.06.1993 No. 2435-XII "On Healthcare" and the Resolution of the Council of Ministers of the Republic of Belarus of 02.08.2008 No. 1269 "On approval of the Regulations on state registration (re-registration) of medical devices and medical equipment".
Medical devices that have passed the state registration procedure before 07/25/2022, but not earlier than 1 year after receiving the Registration Certificate, are subject to re-registration.