Medical Device Registration in EAEU

Registering medical devices by the Eurasian Economic Union (EAEU) regulations is a more complex and time-consuming process. However, it provides access to the markets of all member states through a unified approach to dossier compilation. This registration enables the medical device to be registered across two to five countries.

The registration process generally consists of two stages, each encompassing specific actions and procedures:

Stage 1 – Preparation of the necessary documents for registration, including:

• Preparing the registration dossier, the content of which depends on the class of potential risks associated with the medical device.
• Determining the type of medical device according to the nomenclature classification, and assessing the feasibility of including several modifications of the medical device in a single registration certificate.
• Aligning the manufacturer’s technical and operational documentation with regulatory requirements.
• Collecting evidence of the safety and efficacy of the medical device (tests to evaluate biological action, technical tests, measurement type approval tests, clinical trials).
• The applicant must choose at least one state of recognition, in addition to the reference state, from the EAEU member states where the expert opinion will be coordinated for registering the medical device in these countries.

Stage 2 – Expertise of the registration dossier documents and, in case of a positive outcome, registration of the medical device, which includes:

• Submitting the registration dossier to the authorized body of the reference state and paying state duties.
• The authorized body reviews the completeness and accuracy of the information in the application and dossier. If necessary, it may send the applicant a request that includes comments requiring resolution or a demand for additional information/documents.

For sterile devices of risk class 2a, as well as for all devices of risk classes 2b and 3, a production inspection is conducted in parallel with the document review. This inspection is carried out by an expert institution’s committee, which assesses whether the manufacturer’s certified quality management system complies with mandatory requirements.

Thanks to our deep understanding of evolving regulations, coupled with strong partnerships across the region, we offer optimized navigation through this route. This approach unlocks the vast potential for medical device manufacturers. Our clients consistently gain approval in all targeted member states, achieving this with complete confidence and clarity.