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Resolution of the government of the Kyrgyz Republic
Some changes are planned for the following items according to the laws and regulations governing the circulation and registration of medical devices in Kyrgyzstan:
1. Transition to tracking the status of projects is expected through the personal accounts of applicants;
2. The list of documents of the Master File will include "Certificate for medical device" and "Marketing information";
3. It will be required to provide samples for medical devices that have been evaluated by the regulatory authorities of the countries of the European Union, Australia, Canada, Japan and the United States of America (these devices used to be exempted from analytical testing during registration);
4. Modifications can only be included in one certificate of registration if they refer to one type of medical device in accordance with nomenclature of medical devices (GMDN);
5. An Expert Council will be implemented after completion of specialized examination where Conclusion on effectiveness and safety of the medical device is drawn up;
6. Validity of the Certificate of Registration is unlimited;
7. Certificate of Registration will be subject to cancellation if reasons that led to the suspension of the certificate for six months are not eliminated;
8. The application form for making amendments to the Master File has been published;
9. It is indicated that registration is open until 31.12.2021 within the national procedure.
You can find the project “Resolutions on registration of medical devices” on the website www.medexpert.group in the Section “Legislation”.
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