How to apply for Class II medical device business filing license?
To the enterprise's location in the province, autonomous region, municipality directly under the Central (food) drug supervision and management department or accept the entrusted municipal (food) drug supervision and management agencies apply for "medical device business enterprise license". Application for "medical device business enterprise license", should be submitted to the following information.
1, "Medical Device Business License Application Form".
2, industrial and commercial administration department issued by the enterprise name pre-approval documents.
3, the proposed enterprise quality management personnel ID card, education or title certificate copies and personal resume.
4, the proposed enterprise organization and functions.
5, the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copy.
6, the proposed enterprise product quality management system documents and storage facilities, equipment catalog.
7, the proposed business scope of the enterprise.