One: Overview

The sale, use and circulation of medical devices in Kazakhstan must obtain the medical device registration certificate issued by the Ministry of Health of Kazakhstan;

Kazakhstan medical device registration certificate is valid for 5 years or 7 years;

Second, the main process

1. Preparation of technical documents

2. Notarization of documents (local notarization and notarization of Kazakhstan Embassy)

3. Technical document evaluation

4. Arrange samples to be tested in Kazakhstan (determined according to products)

5. Document evaluation, review and supplement

6. The application was submitted to the Ministry of Health of Kazakhstan and accepted.

7. Expert evaluation and audit documents of Kazakhstan Ministry of Health (Phase I)

8. Clinical document evaluation

9 Kazakhstan Ministry of Health Expert Assessment and Audit Document (Phase II)

10.？ Obtained the registration certificate of medical devices in Kazakhstan

Three. List of technical documents

1. Power of Attorney

2. Application

3. Detailed information of the manufacturer (accurate Chinese and English enterprise name, address, contact person and contact information, etc.). If the registered address is different from the actual production address,

Need to be specified separately);

4. Manufacturer's relevant qualifications (valid business license, organization code certificate, tax registration certificate, trademark certificate, patent certificate,

Export license/free sales license, etc. );

5. EU medical device ce certificate and declaration;

6.ISO 13485 certificate (valid);

7. Product information (accurate product name, model, parts list, customs code, etc. );

8. Product brochure;

9. Product description (in English or Russian, including expected use scope, use requirements, disinfection and sterilization requirements, etc. );

10.？ Product drawings (outline drawings, electrical drawings, packaging drawings);

1 1.？ Product label map (English or Russian);

12.？ Product test report (function, toxicology, clinical report, CE test report, etc.). );

13.？ Risk analysis;

14.？ Others;