Article XII engaged in the operation of Class II medical devices, the business enterprise shall be located in the area of the municipal food and drug supervision and management department for the record, fill out the record of the operation of Class II medical devices form, and submit the information provided for in Article 8 of the 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 certificate, academic or professional title certificate 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 catalog;
(viii) computer information management system basic information and functional description;
(ix) proof of authorization of the operator;
(x) other supporting materials.
Without meeting the relevant requirements can not pass the approval.