What formalities are required for importing medical devices into Russia

Documents to be submitted for the application of medical device registration certificate in Russia:

1. Application form in English or Russian;

2. Power of attorney and declaration;

3. Business license;

4. People's Republic of China (PRC) organization code;

5. ISO13485, ISO9001 system certificate;

6.

6. CE certificate;

7. test report;

8. product description or technical documents;

9. publicity color page;

10. other required information.