1. Application Form for Medical Device Business License
2. Legal representative, person in charge of the enterprise, quality management personnel, ID card, certificate of education or professional title, resume of the person in charge of the enterprise, resignation certificate, resume of the person in charge of quality (with more than 3 years of experience in quality control of medical device management), resignation certificate, etc. If the business scope includes 6846 and 6877, provide 1 the ID card, education background and the copy of the training certificate of the manufacturer or supplier of the operator with college degree or above in medicine-related major. If the business scope includes 6840 clinical laboratory analytical instruments and diagnostic reagents, ID card, copy of academic qualifications or professional titles, work resume, resignation certificate, etc. shall be provided. 1 ID card, education background or title of the person in charge of inspection or quality control who has a college degree or above in laboratory-related major and has been engaged in inspection-related work for more than 3 years, and the acceptance and after-sales service personnel who have a technical secondary school degree or above in laboratory-related major; Business 6822 contact lens and nursing solution, should also provide the operator's relevant professional or professional qualification certificate, contact lens preparation certificate copy, etc.
3. Description of organizational structure and department setting (specific to people);
4. Description of business scope and mode of operation (the business scope lists the 2002 version of the classification catalogue and the corresponding 20 17 version of the classification catalogue);
5. Geographical location map and floor plan (side length, area, zoning, etc.). ) the business premises and warehouse address, and a copy of the house ownership certificate or lease agreement (with the house ownership certificate attached) shall be the business premises; Usually the business premises are more than 40 square meters, and the warehouse area is more than 30 square meters; The business scope includes warehouses 68 15 and 6866, with an area exceeding 100 square meter; If the business scope includes 6846 and 6877, a storage counter shall be set up; Where the business scope includes 6840 (in vitro diagnostic reagents), the business premises are more than 100 square meters, the internal area of the warehouse is more than 60 square meters, and the cold storage is more than 20 cubic meters, which is the warehouse; Among them, the business area is 6822- 1, the business place area is greater than 10 square meter, and the warehouse area (warehouse counter) is greater than 1 square meter; The business area of retail enterprises should be increased by more than 25 square meters on the basis of pharmaceutical retail enterprises.
6. Catalogue of operating facilities and equipment;
7. Catalogue of quality management system (18 or more), and the catalogue of quality management system shall be provided for those who engage in 6840 in-vitro diagnostic reagents;
8. Basic introduction and function description of computer information management system and various screenshots;
9. The authorization certificate of the agent (with a copy of ID card);
10. Other supporting materials (commitment letter, roster, copy of product registration certificate, etc. ).