1, the enterprise's Class II medical device business record application form.
2, the enterprise's legal representative, responsible person, quality responsible person's identification, education or title certificate copy.
3, the enterprise's business license and organization code certificate copy.
4, the scope of business and a description of the mode of operation.
5, submit a catalog of business facilities and equipment.
6, organizational structure and departmental setup description.
7, enterprise business quality management system, work procedures and other documents catalog.
8, the authorization of the operator's certificate.
9, business premises, warehouse address plan, geographic location map, a copy of the document proving ownership of the house or a copy of the lease agreement.
10, if the business enterprise to establish a computer information management system in line with the quality management requirements of medical devices, the need to have a basic introduction and functional description, no need to explain.
11, need to submit other supporting materials.