Starting 28 October 2026, the Eurasian Economic Union (EAEU) expands the grounds for suspending a medical-device registration certificate. One new ground is the absence of a current manufacturing inspection report in the registration dossier. The change applies in Kazakhstan as an EAEU member.
The Council of the Eurasian Economic Commission amended the rules on registration and expert review of medical devices through Decision No. 104 of 9 September 2026. Under the update, authorities may suspend a registration if the manufacturer’s dossier does not contain a valid report on the results of a production inspection.
Limited exemptions apply: manufacturers of class 1 devices and of non-sterile class 2a devices are carved out of this particular ground. Where an inspection application was filed on time and the manufacturer received the required notice together with copies of the application and the contract with the inspecting organisation, suspension linked to an expired prior report may not start earlier than 25 working days after that report’s end date.
For manufacturers and distributors placing devices on the Kazakhstan market under EAEU registration, the practical message is clear: keep inspection documentation current and monitor dossier completeness. iPharma follows regulatory developments that affect how medicines and medical devices reach pharmacies and clinics in Kazakhstan.
This summary is based on reporting by Pharmnews.kz; always verify against the official EEC decision text.