2. A copy of the applicant's qualification certificate (if entrusting others, the power of attorney signed by the applicant and the identity certificate of the client shall also be attached);
3. A copy of the business license;
4. Copy and resume of quality manager qualification certificate (college degree or above in medical equipment, biomedical engineering, mechanical electronics, ID card, graduation certificate or professional title certificate);
5. A copy of the geographical location map, functional layout map, house title certificate and lease agreement of the business premises and warehouse address;
6. Description of business scope and mode of operation.
7. Catalogue of operating facilities and equipment;
8. Manage the quality management system, working procedures and other documents;
9. Basic introduction and functional description of computer information management system;
10. Authorization certificate of the agent;
1 1. If it contains in vitro reagents, it needs to be refrigerated.
The application conditions for the third type of medical device license:
1. There are quality management institutions or quality management personnel suitable for the business scope and scale, and the quality management personnel shall have relevant professional qualifications or titles recognized by the state;
2. Having business and storage places suitable for the business scope and scale;
2. 1 To engage in the wholesale operation of in vitro diagnostic reagents, the following conditions shall be met:
2. 1. 1 The construction area of the business premises shall not be less than 100 square meter, the construction area of the warehouse shall not be less than 60 square meters, and the capacity of the cold storage shall not be less than 20 cubic meters.
2. 1.2 cold storage should be equipped with automatic monitoring, adjustment, display and recording of temperature status and automatic alarm equipment, standby generator set or installation of two-way circuit, and standby refrigeration unit.
2. 1.3 There should be a refrigerated truck or refrigerator that can automatically display the temperature, which is suitable for the business scale and variety and meets the requirements of the storage temperature of in vitro diagnostic reagents.
2.2 In the wholesale business of other types of tertiary medical devices, the construction area of the business premises shall not be less than 100 square meter, and the warehouse area shall be suitable for the business scope:
2.2. 1 If the business code is 68 15, the building area of the warehouse shall not be less than 200m2. ?
2.2.2 Where the business code is 682 1 Medical Electronic Instruments and Equipment, 6822 Medical Optical Instruments, Instruments and Endoscopic Equipment, 6846 Implantable Artificial Organs and 6877 Interventional Instruments, the construction area of the warehouse shall not be less than 80 square meters.
2.2.3 For Class III medical devices other than the above-mentioned category codes, the building area of the warehouse shall not be less than 60 square meters. ?
2.3 To engage in the retail business of Class III medical devices, the business premises and warehouses shall meet the following requirements:
2.3. 1 A retail enterprise specializing in Class III medical devices shall have a business place with a construction area of not less than 60 square meters and a warehouse that meets the requirements. ?
2.3.2 Retail enterprises dealing in contact lenses and nursing solutions should have independent counters; To provide fitting services, the construction area of the business premises shall not be less than 30 square meters, and it shall be equipped with facilities and equipment required for fitting, such as computer optometry instrument and slit lamp; Optometry room (area) should have darkroom conditions or meet the conditions of no direct light.
2.3.3 Retail enterprises that run other types of Class III medical devices concurrently shall set up special areas (cabinets) in their business premises, and the conditions of the special areas (cabinets) shall meet the storage characteristics requirements of the medical device products they operate.
2.4 The business premises and warehouses of operating enterprises shall not be located in residential buildings, military administrative zones (excluding leasable zones) and other places that are not suitable for operation. Warehouse location should take into account the principle of convenient management and the nearest business premises.
2.5 The display conditions of the business premises of a single-store retail enterprise can meet the performance requirements of the medical device products it operates, and the business premises can meet the needs of its business scale and variety display; Medical device chain retail business; All entrusted to other medical device management enterprises for storage; Those who specialize in medical equipment software or medical magnetic vibration, medical X-rays, medical high-energy rays, medical radionuclide equipment and other large medical equipment may not set up warehouses.
3. It has storage conditions suitable for the business scope and scale, and it is not necessary to set up a warehouse if it is all entrusted to other medical device business enterprises for storage;
4. It has a quality management system suitable for the medical devices it operates;
5 have the ability to provide professional guidance, technical training and after-sales service suitable for the medical devices they operate, or agree to provide technical support by relevant institutions.
6. It has a computer information management system that meets the requirements of medical device management quality management, and ensures the traceability of the products it operates.