Basis: "Regulations" Article XII engaged in the second class of medical equipment business, the business enterprise shall be located in the municipal food and drug supervision and management department for the record, fill out the second class of medical equipment business filing form, and submit the information provided for in Article 8 of these measures (except for the eighth item).
Article VIII engaged in the third class of medical equipment business, the business enterprise shall apply to the municipal food and drug supervision and management department of the location of the district, and submit the following information:
(a) business license and organization code certificate copy;
(b) legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the identification, education, or proof of professional title Copies;
(C) organization and departmental setup description;
(D) business scope, business mode description;
(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or a copy of the lease agreement (with documents proving ownership of the house);
(F) business facilities, equipment directory;
(vii) business quality management system, work procedures and other documents directory;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization by the operator;
(x) other supporting materials.