State registration of medical devices
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
Which types of medical devices are subject to state registration?
Registration of medical devices is regulated by the Law of the Republic of Belarus of 18.06.1993 No. 2435–XII "About Healthcare" and 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".
- The diagnostics equipment, prevention, treatment, rehabilitation
- Surgical instruments and materials
- Consumables, accessories
- Devices for health monitoring and self monitoring
- Laboratory equipment
- Reagents and reagents for in vitro diagnostics
- Personal protective equipment
- Other medical devices