1) "Medical Device Business License Application Form";
2) business name pre-approval issued by the administrative department of industry and commerce to prove the document;
3) the proposed enterprise quality manager's identity card, academic qualifications, a copy of the certificate of title and personal resume;
4) the proposed business Organizational structure and functions;
5) the proposed enterprise registered address, warehouse address of the geographic location map, floor plan (indicating the area), a copy of proof of ownership of the house (or lease agreement);
6) the proposed enterprise product quality management system documents and storage facilities, equipment directory;
7) the proposed scope of business.
8) with the scale and scope of business with the quality management organization or full-time quality manager. Quality management personnel should have a nationally recognized relevant professional or professional title;
9) with the business norms and business scope of the relatively independent premises;
10) with the business norms and business scope of the storage conditions, including with the requirements of the characteristics of medical equipment product storage facilities, equipment;
11) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking and quality of bad time reporting system;
12) should have the appropriate technical training and after-sales service capacity with its business medical device products, or agreed to provide technical support by a third party