Re: Medical Device Regulations for CIS Countries
Hi -
Hope this helps. It is a listing that one of our distributors (glucose monitoring systems) sent to us for the requirements for Kazakhstan.
Enclosure 4
To the regulations of State registration (re-registration) of medical means including medical equipment and amendments to registration file on medical means including medical equipment.
List of documents required for registration or re-registration of medical equipment
1. Application in the approved format (both in electronic and hard copies).
2. Document confirmed the State Registration or copy of the State Registration of the manufacturer’s enterprise issued in the country of manufacture, which includes a list of all components (main parts and components, materials).
3. Information of registration in other countries confirmed by the copies of registration certificates.
4. Power of Attorney from the manufacturer allowed registration process execution. Notarized by the Notary Public
5. **Certificate of sale permission (export permit).
6. ***Certificates confirmed that product complies with the requirements of international or national standards, including conditions of product manufacture (Quality Certificate issued in the country of manufacture).
7. Copy of the Registration Certificate of a tool as a measurement instrument issued by country of manufacture or other countries.
8. Methods of measurement instruments testing
9. Copy of the document (minutes, reports) of medical measurement instrument tests approval, executed in the country of manufacture or other countries.
10. Copies of toxicological hazard test safety reports (minutes) executed in the country of manufacture including exact specifications of the components of proposed medical equipment.
11. Copies of the documents (reports) of technical tests executed in the country of manufacture on medical equipment.
12. Copy of the report of medical tests executed in the country of manufacture.
13. Copy of the sanitary inspection report executed in the country of manufacture on medical equipment.
14. Report of precious metal occurrence or its absence (including quantity) in proposed medical equipment.
15. Operating Manual on proposed medical equipment approved by the manufacturer’s official seal.
16. Draft Operating Manual for the medical staff, in Russian (both in electronic and hardcopy formats), see p. 15.
17. Draft Operating Manual (note, insert) for the consumers, both in the language of manufacturer’s country and Russian (both in electronic and hardcopy formats), see p. 15.
18. Sample of medical devices (in quantities sufficient for the tests repeated three times). If necessary, samples of medical equipment, required for clinical tests, should be provided.
19. Information of stability (for medical equipment), not less than in tree series.
20. Normative documents on packaging materials for medical equipment.
21. Promotional illustrative materials.
22. Photograph, minimum size 130x180 mm.
23. Color models of packaging and labels for medical equipment (both in electronic and hardcopy formats). Certified by the official seal of the applicant.
24. Copy of a patent or other product certificate
Notes:
** Documents required only for the manufacturers from the foreign countries.
***Documents required for the manufacturers from both foreign countries and newly independent States.
Documents not marked specifically are required for all applicants.
Documents should be submitted in the language of manufacturer’s country and Russian (2 originals and 2 notarized copies including Apostille.
Good Luck!!
Beth
