2 copies of business license and organization code certificate (original and copy)
3, the legal representative, the person in charge of the enterprise, the person in charge of the qualification certificate, diploma or title certificate copy.
4, organization and department settings (organization chart, department functions, staff roster)
5. Description of business scope and mode of operation (the business scope and mode of operation of the three types of medical devices are the same as the application form)
6. Geographical map of business premises and warehouse address (indicating the name of adjacent street and surrounding landmark buildings), floor plan (indicating the size, area and regional division), house property certificate or a copy of lease agreement (the lease agreement must be accompanied by house property certificate).
7, business facilities and equipment directory (office and storage facilities and equipment, storage and transportation equipment of refrigerated products, refer to the fourth chapter of this specification)
8, management quality management system, working procedures and other documents directory (must include the requirements stipulated in Article 8 and Article 9)
9. Basic introduction and function description of computer information management system (see Article 30 of this specification for software name, introduction and function description)
10. Original certificate of agent's authorization (name, ID number, authorization period and authorization items, with a copy of ID card attached).
1 1, other supporting materials.