Which organization is responsible for medical device registration in Kazakhstan

Medical device registration in Kazakhstan

I: Overview

Medical devices are required to obtain a medical device registration certificate issued by the Ministry of Health of Kazakhstan for their sale, use and circulation in Kazakhstan;

The certificate of registration of a medical device in Kazakhstan is valid for 5 years or 7 years;

II: Main processes

1.? Preparation of technical documents

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

3.? Evaluation of technical documents

4.? Arrangement of sample testing in Kazakhstan (depending on the product)

5.? Document evaluation, review and supplementation

? 6.? Submission and acceptance of application to the Ministry of Health of Kazakhstan

? 7.? Evaluation and review of documents by experts of the Ministry of Health of Kazakhstan (Phase I)

8.? Evaluation of clinical documentation

9.? Kazakhstan Ministry of Health expert assessment, review of documents (Phase II)

10.? Obtaining the certificate of medical device registration in Kazakhstan

3: List of technical documents

1.? Authorization letter

2.? Application form

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

detailed description is required separately);

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

export license/free sale certificate, etc.);

5.? CE certificate and declaration for EU medical devices;

6.? ISO13485 certificate (within the validity period);

7.? Product information (accurate product name in English and Russian, model number, parts list, customs code, etc.);

8.? Product brochures;

9.? Product manual (English or Russian, including the scope of intended use of the product, use requirements, sterilization requirements, etc.);

10. Product drawings (appearance, electrical diagrams, packaging drawings);

11.? Product labeling diagram (English or Russian);

12.? Product test reports (functionality, toxicology, clinical reports, CE test reports, etc.);

13. Risk analysis;

14.? Others;