Registration of medical devices in the EAEU

Mandatory requirements for placing a medical device into circulation within the Eurasian Economic Union include its registration and expert evaluation, which are conducted by the competent authority of the reference state. Identical requirements apply both to medical devices produced within the EAEU territory and to those imported from third countries into the customs territory of the Union. The registration procedure involves the issuance of official authorisation by the competent authority, granting the right to medical use and free circulation of the device across all EAEU member states.

Which medical devices are subject to mandatory registration?

The circulation of medical devices within the Eurasian Economic Union is regulated by a comprehensive legal framework designed to ensure the safety, quality, and efficacy of all devices admitted to the market. This framework establishes uniform requirements applicable to all member states, eliminating regulatory barriers and creating equal conditions for manufacturers. Key documents governing this area include:

Treaty on the Eurasian Economic Union of 29 May 2014
Agreement on Uniform Principles and Rules for the Circulation of Medical Devices within the EAEU of 23 December 2014
Other international treaties and acts constituting Union law
Decisions of the Eurasian Economic Commission
National legislation of the EAEU member states

Registration procedures are conducted strictly in accordance with the Rules established by Decision of the Council of the Eurasian Economic Commission No. 46 of 12 February 2016, ensuring a unified and transparent approach to medical device authorisation across all member states. Compliance with this regulatory framework is a mandatory condition for any manufacturer seeking to place their products into lawful circulation within the EAEU market.

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

REGISTRATION STAGES:

Compilation of the registration dossier. Gathering the complete set of required documentation

Preliminary review of the registration dossier. Assessment of the collected document package and introduction of necessary corrections

Selection of accredited testing laboratories within the EAEU

Development of a testing programme. Drafting and coordination of the testing programme with the manufacturer and selected laboratories

Conducting tests. Obtaining permission to import medical device samples and carrying out required testing

Finalisation of the dossier. Preparation of documents for submission to the state authority of the reference country and conversion of the dossier into XML format

Initiation of the registration procedure. Concluding an agreement with the state authority, payment of expert services, and official submission of the dossier

Inspection of medical device manufacturing. Assessment of production conditions and the quality management system of the manufacturer for compliance with established requirements

Coordination of the expert conclusion by the competent authority of the reference state with the relevant member states

Completion of registration. Entry of information into the EAEU register and issuance of the registration certificate

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