Article 8 To engage 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 in which it is located and submit the following information:
(a) a copy of the business license and the organization code certificate;
(b) a copy of the legal representative, person in charge of the enterprise, the person in charge of quality (B) the legal representative, the person in charge of business, quality, identity certification, education or 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 building or lease agreement (with documents proving ownership of the building) 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;
(ix) proof of authorization of the operator;
(j) other supporting materials.
Article XII engaged in the second class of medical devices 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 devices business record form, and submit the information provided for in Article 8 of these Measures (except for the eighth item).
For a class of medical device business, now has liberalized management.