Registration of medical devices in the EAEU
Registration and expert examination of a medical device are mandatory conditions for its release into circulation within the Eurasian Economic Union and are carried out by the authorised body of the reference state. At the same time, the same requirements apply to medical devices manufactured within the territory of the Eurasian Economic Union and medical devices imported into the customs territory of the Eurasian Economic Union from third countries. Registration of medical devices is a procedure for issuing permission by the authorised body for medical use and circulation of a medical device within the Eurasian Economic Union.
What types of medical devices need to be registered?
The regulation of the circulation of medical devices in the framework of the EAEU is carried out in accordance with the Treaty on the Eurasian Economic Union dated 29 May 2014, the Agreement on common principles and rules for the circulation of medical devices (medical products and medical equipment) in the framework of the Eurasian Economic Union dated 23 December 2014, other international treaties and agreements constituting the law of the Union, decisions of the Commission, as well as with the laws of the Member States. Registration of medical devices is carried out in accordance with the Rules approved by Decision of the Council of the Eurasian Economic Commission No. 46 dated 12 February 2016.
- Diagnostic equipment
- Surgical instruments and materials
- Consumables
- Patient monitoring devices
- Ophthalmic medical products
- Dental medical products
- Equipment/furniture
- Medical products
- Laboratory equipment
- Reagents
- Personal protective equipment
- Other medical devices
