Kazakhstan Updates Medical Device Registration Framework as EAEU Transition Nears

Kazakhstan has introduced significant regulatory changes to its medical device and pharmaceutical registration framework as the country continues to align with wider Eurasian Economic Union (EAEU) requirements. These developments impact manufacturers, authorised representatives, and importers seeking market access in Kazakhstan and across the EAEU.

Amendments to Registration Procedures (Nov 2025)

On 18 November 2025, Kazakhstan’s Ministry of Health issued amendments to the rules governing state registration, re-registration, and changes to dossiers for both medicinal products and medical devices. These changes clarify procedural requirements for obtaining and updating registration certificates and align local practice with evolving regulatory expectations.

Under the updated provisions:

• Registration certificates for devices and medicines will continue to be issued with defined validity and procedural expectations.

• Re-registration and change submissions require adherence to a more defined administrative framework, helping ensure consistent documentation and lifecycle oversight.

These updates provide manufacturers with clearer timelines and procedural standards for maintaining compliance in Kazakhstan’s regulatory environment.

EAEU Registration Transition Important Deadline

Kazakhstan, as a member of the Eurasian Economic Union, is adjusting its approach to device registration as the EAEU’s harmonised regulatory scheme takes effect.

Under current EAEU decisions, the national registration procedures in member states were set to be phased out by 31 December 2025. However, amendments now permit registration certificates issued under national rules to remain valid after that deadline under certain conditions, including:

• Products registered under national legislation before 31 December 2025 may continue to be marketed until the certificate expires.

• Re-registration under national rules may be possible if the application is filed before 31 December 2026.

  
  

This transitional arrangement provides important continuity for manufacturers and distributors who initiated national registration before year-end, reducing the risk of regulatory disruption as the EAEU framework becomes mandatory.

Kazakhstan & Turkey Cooperation on Digital Health

In parallel with these regulatory shifts, Kazakhstan and Turkey are preparing a cooperation agreement on the digitalisation of medicine. Officials from both countries met in Ankara to discuss knowledge exchange and expanded partnership in areas including digital health technology and artificial intelligence in healthcare systems. Such strategic collaboration signals a regional trend toward harmonised digital health standards and broader regulatory cooperation on emerging medical technologies.

What This Means for Industry

For medical device manufacturers and stakeholders operating in Kazakhstan and the EAEU region, these developments carry several implications:

• Timing and Transition: Companies with ongoing national registrations should act quickly to submit applications before the EAEU deadline to preserve certificate validity beyond 2025.

• Regulatory Planning: Updated procedures and timelines for registration and dossier changes require careful compliance planning and resource allocation.

• Digital Health Readiness: The emerging emphasis on digitalisation in healthcare underscores the need for regulatory strategies that incorporate digital health and AI components where relevant.

These combined developments reflect Kazakhstan’s dual focus on regulatory harmonisation with the EAEU and forward-looking cooperation with regional partners on digital health innovation. As the regulatory landscape evolves, proactive engagement and strategic planning will be critical for securing and maintaining market access.

Source: Government and Ministry of Health public information (Kazakhstan)