How to apply for Class II medical device business record license?
To the enterprise's location in the provinces, autonomous regions, municipalities 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.
Two types of medical sales online filing process?
The second class of medical devices online filing process:
Application for the second class of medical devices business record should be submitted to the information:
1, business license;
2, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person in charge of the certificate, education or title certificate;
3, the organization and the departmental setup instructions;
4, business scope, business mode description;
5, business premises, warehouse address of the geographic location map, floor plan, documents proving property rights of housing or lease agreement; (with documents proving property rights of housing)
6, business facilities, equipment directory;
7, business quality management system, work procedures and other documents directory;
8, to encourage the Use of computer information management system;
9, proof of authorization of the operator;
10, signed and stamped scanned application form;
11, other supporting materials.