The Registration of medical devices in the European-Asian Economic Union
Registration and examination of a medical device are mandatory conditions for its release into circulation on the territory of the European-Asian Economic Union and are carried out by the authorized body of the reference state. At the same time, the same requirements are imposed on medical devices manufactured in the territory of the member states of the Union and imported into the customs territory of the European-Asian Economic Union from third states.
Medical equipment registration is a procedure for issuing a permit by an authorized body for the medical use and circulation of a medical device on the territory of the European-Asian Economic Union.
WHAT TYPES OF MEDICAL DEVICES NEED TO BE REGISTERED?
Regulation of the circulation of medical devices within the European-Asian Economic Union is carried out in accordance with the Treaty on the Eurasian Economic Union of May 29, 2014, the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Devices and Medical Equipment) within the Eurasian Economic Union of December 23, 2014, other international treaties constituting the law of the Union, Commission decisions, as well as the laws of the member states. Registration of medical devices is carried out according to the Rules approved by the Decision of the Council of the Eurasian Economic Commission No. 46 dated 12.02.2016.
- Equipment for diagnostics, prevention, treatment, rehabilitation
- Surgical instruments and materials
- Consumables, accessories
- Devices for health monitoring and self
- Laboratory equipment
- Reagents and reagents for in vitro diagnostics
- Personal protective equipment
- Other medical devices