"Supervision and Administration of Medical Devices" (State Food and Drug Administration Decree No. 8)
Article VIII Engaged in the operation of Class III medical devices, the business enterprise shall apply to the municipal food and drug supervision and management department of the district where the location of the application, and submit the following information:
(a) business license and organization code certificate Copies;
(B) legal representative, the person in charge of the enterprise, the quality of the person in charge of the identification, education or title certificate copies;
(C) organizational structure and departmental setup description;
(D) the scope of business, the mode of operation description;
(E) the business premises, warehouse address of the geographic location of the map, floor plan, house ownership Proof of documents or lease agreement (with documents proving ownership of the house) copies;
(F) business facilities, equipment directory;
(G) business quality management system, work procedures and other documents directory;
(H) computer information management system basic information and functional description;
(I) the operator's authorization certificate;
(J) other supporting materials.