Do you need a license to export medical devices?

Exporting medical devices need a license, you need to provide medical device business license.

Medical equipment business license is a medical device business enterprises must have the documents, the opening of the second class of medical equipment business enterprises, should be to the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for the record; the opening of the third class of medical equipment business enterprises, should be by the provinces, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department for examination and approval, and issued the "Medical Device Business Enterprise License".

Medical equipment business license is now a post approval, industrial and commercial administration department issued a business license to apply for approval. The Medical Device Business License is valid for 5 years.

Extended information:

Management of medical device products export sales certificate Provisions:

Article 1 In order to further standardize the food and drug supervision and management department to issue medical device export sales certificate of service matters, to facilitate the export of medical device manufacturers products, it is hereby formulated this provision.

Second, in our country has obtained a medical device product registration certificate and production license certificate, or has been for the record of medical device products and production record, food and drug supervision and management departments can issue for the relevant manufacturers of "medical device products export sales certificate.

Article 3 The provincial food and drug supervision and management department where the enterprise is located is responsible for the administrative region of the "medical device products export sales certificate" management.

Article IV The enterprise shall submit to the local provincial food and drug supervision and management department or its designated department, "medical device products export sales certificate registration form", and submit the following information stamped with the official seal of the enterprise, the content of the information should be consistent with the actual information of the exported products.

Baidu Encyclopedia-Medical Device License

State Food and Drug Administration - on the release of medical device products export sales certificate management regulations