1. Medical device business filing form; business license and a copy of the organization code certificate; 2. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person, a copy of the certificate of qualifications or titles; 3. Organizational structure and departmental setup description; 4. Scope of business, the mode of operation description; business premises, warehouse address of the geographic location of the map, the floor plan, Documents proving the ownership of the house or a copy of the lease certificate issued by the housing rental; 5. Business facilities, equipment directory; 6. Business quality management system, working procedures and other documents directory; 7.