Medical Devices Registration in EAEU countries

If you're planning to bring your medical devices to Russia, Belarus, Kazakhstan, Armenia, or Kyrgyzstan — you need to register through the unified EAEU system. This process ensures that once your device is approved, it can be sold across all five countries without repeating registration procedures.

We help manufacturers to handle this complex process with confidence.

The Eurasian Economic Union (EAEU) introduced a common set of rules for medical device registration. This allows manufacturers to obtain one certificate that covers all member states — simplifying access to a market of over 180 million people.

The process includes:

• Official representation inside the EAEU
  You must have a local representative authorized to submit documents and act on your behalf.
   
• Comprehensive technical documentation
  Files must follow the EAEU’s specific structure and include clinical evaluations, risk assessments, labeling, and manufacturing details.
   
• Testing and expert review
  Devices are tested in accredited labs. Depending on the risk class, clinical data or trials may be required.
   
• Centralized approval
  Once your file passes expert review, you receive a registration certificate valid in all EAEU countries.

We offer full guidance from start to finish:

• Product classification and strategy planning
  
• Document review and adaptation to EAEU format
   
• Coordination with laboratories and testing centers
   
• Preparation of clinical evidence
   
• Certified translation of documentation
   
• Authorized Representative services inside the EAEU
   
• Communication with regulatory authorities

EAEU registration is not just a formality — it’s a technical and legal process. Mistakes in documentation, missing data, or non-compliant translations can lead to rejection or serious delays.

Working with a team that understands both the regulatory requirements and local practices gives you a real competitive edge.

Looking to expand into the EAEU region? We make the process manageable and reliable — from first steps to final approval.
Write to us at: info@lb-med.com