(a) apply for the establishment of a medical device business report, fill out or print the "Medical Device Business License Application Form" (four copies);
(b) the administrative department for industry and commerce issued the "pre-approval of the enterprise name notification";
(c) the information of personnel;
1 The proposed legal representative and the person in charge of the enterprise's identity card, household register or relevant certificates issued by the public security organs and other documents and educational certificates, health certificates;
2, the proposed quality management personnel of the enterprise's identity card, copies of certificates of academic or professional and technical positions and individual practitioner's resume, employment agreement, and health certificates;
3, the proposed roster of personnel of the enterprise, as well as health certificates The roster includes The content of the roster includes: name, gender, age, professional and technical positions/education, position/position.
(4) the proposed enterprise organization and functions;
enterprises to develop the organizational structure of the block diagram, clearly and unambiguously identifies the internal division of labor within the enterprise, as well as the functions of the enterprise personnel positions.
(E) the proposed enterprise registered address, warehouse address of the geographical location map, floor plan (indicating the area), proof of ownership of housing (or lease agreement) copy.
(F) the proposed enterprise product quality management system documents and storage facilities, equipment catalog;
(G) the proposed enterprise business varieties catalog;
Catalog includes the following: product name, manufacturer, specifications, registration certificate number, and the corresponding product storage conditions, requirements of the description.