Russian Medical Device RegistrationRussian Certification

The Russian Medical Device Registration Certificate is issued by Roszdravnadzor. To export medical devices to Russia, manufacturers must obtain the medical device license issued by Roszdravnadzor and the GOST-R certificate. With headquarters located in Moscow, we can submit documents and complete local registration procedures at the Russian Ministry of Health.

Products cannot be sold or used in Russia without the locally issued medical device license and GOST-R certificate. This registration certificate is valid permanently. To apply for the GOST-R certificate for medical devices, enterprises must first obtain the medical device license from Roszdravnadzor.

Required Documents for Application

1. Application form in English or Russian;

2. Power of attorney and declaration;

3. Business license;

4. China Organization Code;

5. ISO13485 and ISO9001 certificates;

6. CE certificate;

7. Test reports;

8. Product descriptions and technical documents;

9. Product brochures;

10. Other required materials.

Documents Needing Notarization by CCPIT or Embassy

1. Power of attorney and declaration;

2. Business license of the legal entity;

3. ISO9001 and ISO13485 system certificates;

4. CE certificate.

GOST-R Conformity Assessment Procedures

1. Submit certification application, power of attorney and declaration;

2. Expert evaluation and customized certification plan formulation;

3. Prepare application documents under the guidance of professional certification engineers;

4. Assist enterprises in completing notarization via CCPIT or embassies;

5. Sample delivery and testing as required;

6. Institutional review of factory qualifications and submitted documents, followed by draft certificate issuance;

7. Issue the official certificate in electronic and hard copy versions.