Kazakhstan Medical Device Registration CIS National Certification

Medical devices sold, used and circulated in Kazakhstan must obtain a medical device registration certificate issued by the Ministry of Health of Kazakhstan. The registration certificate is valid for 5 years.

Main Procedures for Kazakhstan Medical Device Registration:

1. Preparation of technical documents;

2. Document notarization (local notarization and Kazakhstan embassy notarization);

3. Technical document assessment;

4. Arrange sample testing in Kazakhstan (determined by product type);

5. Document review, assessment and supplementation;

6. Submit application to the Ministry of Health of Kazakhstan and accept acceptance;

7. Phase 1 document review and assessment by ministry experts;

8. Clinical document evaluation;

9. Phase 2 document review and assessment by ministry experts;

10. On-site factory audit by Kazakhstan health authority experts;

11. Issuance of Kazakhstan medical device registration certificate.

Technical Document List for Registration:

1. Authorization letter;

2. Application form;

3. Manufacturer details (name, address, contact info; specify separately if registered address differs from production address);

4. Manufacturer qualifications (business license, organization code, tax certificate, trademark, patent, free sales certificate, etc.);

5. EU medical device CE certificate & declaration;

6. Valid ISO13485 certificate;

7. Product information (English & Russian name, model, BOM, HS code);

8. Product brochure;

9. IFU (English / Russian: intended use, operation, sterilization requirements);

10. Product drawings (appearance, electric, packaging);

11. Product label artwork (English / Russian);

12. Test reports (function, toxicology, clinical, CE test, etc.);

13. Risk analysis document.