Medical equipment exported to Russia needs to obtain the medical equipment license and GOST-R certificate issued by the Russian Federal Department of health and social development supervision (Roszdravnadzor). Without the medical equipment license and gost r certificate issued by Russia, it cannot be sold and used in Russia. The registration certificate is valid for a long time.

To obtain the gost r certificate of medical equipment, we must first obtain the medical device license from the Ministry of health and social development supervision of residents of the Russian Federation.

1： Overview

The sale, use and circulation of medical devices in Russia must obtain the medical device registration certificate and the corresponding GOST-R (DOC) certificate issued by the Russian Ministry of health;

The medical device registration certificate is valid for life;

GOST-R (DOC) certificate is valid for 1/3/5 years;

2： Main process

1. Preparation of technical documents

2. Document notarization

3. Evaluation of technical documents

4. Arrange samples to Moscow for testing (toxicology, etc.)

5. Document evaluation, review and supplement

6. Submit the application to the Ministry of health of Russia and accept it

7. Evaluation and review documents of experts from the Russian Ministry of Health (phase I)

8. Clinical trials (determined according to products)

9. Evaluation and review documents of experts from the Russian Ministry of Health (phase II)

10. Obtain the Russian medical device registration certificate

11. Audit and evaluation documents of Russian certified experts

12. Obtain Russian GOST-R (DOC) Certificate

3： List of technical documents

1. Power of attorney

2. Application form

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

Need to be specified separately);

4. Relevant qualifications of the manufacturer (valid business license, organization code certificate, tax registration certificate, trademark certificate, patent certificate, export license / free sales certificate, etc.);

5. EU medical device CE certificate and declaration;

6. ISO13485 Certificate (within the validity period);

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

8. Product brochure;

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

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

11. Product label drawing (English or Russian);

12. Product test reports (functional, toxicological, clinical, CE test reports, etc.);

13. Risk analysis;

14. Others;

Since Russia lifted the ban on the import of medical products, more and more medical products in China will enter the markets of Russia and other countries of the customs union. Among the large influx of medical products, only those products that have passed the formal process of certification can be successfully sold in the Russian market. Therefore, medical certification and registration is the top priority, and the most important of all.

In addition to the above Russian medical registration at home and abroad, our company can also handle CE certification, customs union EAC certification, gost certification, product CE certification, export and product certification of many countries and regions, such as Africa Nigeria SONCAP, Kenya PVOC, Tanzania COC certification, etc. as a trusted partner of the enterprise, we can help you sail in the international market