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
  • prevention, treatment, rehabilitation, including special software
  • Surgical instruments and materials
  • Consumables
  • accessories for equipment and devices
  • Patient monitoring devices
  • health and self-control
  • Ophthalmic medical products
  • Dental medical products
  • Equipment/furniture
  • for special patient care
  • Medical products
  • sterile/non-sterile
  • Laboratory equipment
  • Reagents
  • for in vitro diagnostics
  • Personal protective equipment
  • Other medical devices


Preparation of the registration dossier. Collection of all necessary documents
Preliminary analysis of the registration dossier. Evaluation of the collected package of documents and making adjustments
Selection of accredited laboratories within the EAEU
Drawing up a test programme. Drawing up and coordination of the test programme with the manufacturer and the laboratories
Testing. Obtaining a permit to import samples of medical devices and testing
Preparation of the final dossier. Preparation of the dossier for submission to the state body of the reference country and conversion of the dossier to XML format
Applying for the procedure. Conclusion of an agreement with the state body, payment for expert work, submission of the dossier to the state body
Inspection of the production of the medical device. Evaluation of the production conditions and the QMS of the manufacturer of the medical device in terms of compliance with the requirements
Coordination of the expert opinion by the authorised body of the reference state with the Member States concerned
Registration of the medical device. Placing the information in the EAEU register and receiving the registration certificate
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