1. Medical device business license application form
2. Scanned copies of the legal representative, the person in charge of the enterprise, the quality management personnel, ID card, education or title certificate, the person in charge of the enterprise's work resume, proof of departure, the person in charge of the quality of the work resume (must be more than 3 years engaged in the operation of medical equipment quality control work experience), proof of departure, etc.. The business scope contains 6846, 6877, should provide a college degree or above in medicine-related professional business personnel with identity cards, academic qualifications and manufacturers or suppliers of training certificates, etc.; business scope contains 6840 clinical testing and analysis of instruments and diagnostic reagents, should provide a supervisor of the examiner or with a college degree or above in testing and testing-related work for more than 3 years Quality control personnel's identity card, education or title certificate copies, work resume, proof of separation, etc., and at the same time to provide one with secondary school education in testing-related disciplines or junior title or more acceptance and after-sales service personnel's identity card, education or title copies, etc.; operation of the 6822 corneal contact lenses and care of the liquid, should be provided at the same time to operate the staff of the relevant professional or vocational qualifications, Contact lens dispensing certificate copy, etc..
3. Organizational structure and departmental setup (specific to the person) description;
4. Business scope, business mode description (business scope of the 2002 Classification List and the corresponding 2017 version of the Classification List);
5. Business premises, warehouses and addresses of the geographic location of the map, the floor plan (length, area, zoning, etc.), documents proving the ownership of the building or Lease agreement (with documents proving ownership of the house) a copy, should be commercial premises; usually business premises area of 40 square feet or more, warehouse area of 30 square feet or more; business scope contains 6815, 6866 warehouse area of 100 square feet or more; business scope contains 6846, 6877 should be set up to store special cabinets; business scope contains 6840 (in vitro diagnostic reagents), the business premises 100 square feet or more, more than 60 square feet of warehouse set area, more than 20 cubic meters of cold storage, and for the warehouse in the warehouse; operation of 6822-1, the business premises area of 10 square feet or more, the warehouse area (storage cabinets) of more than 1 square feet; retail enterprises should be based on the area of the premises of the pharmaceutical retail enterprises to increase the area of more than 25 square feet.
6. Business facilities, equipment directory;
7. Business quality management system (more than 18) directory, business 6840 in vitro diagnostic reagents should be provided in addition to the quality management system directory;
8. Computer information management system basic information and functional description and a variety of screenshots;
9. Certificate of authorization (with ID card);
9. Copy);
10. Other supporting materials (commitment, roster, a copy of the product registration certificate, etc.).