1, office area of not less than 40 square feet; (business building or storefront store);
2, warehouse area of not less than 15 square feet; (my company can provide) (three types of in vitro diagnostic reagents containing a time the need for frozen warehouses);
3, including three types of disposable supplies, then the requirements of the office Address and warehouse area together can not be less than 160 square feet;
If the warehouse entrusted to a third-party logistics company, you need to have a medical device license qualification of the logistics company can be.
Second, for the second class of medical devices business record personnel requirements:
1, with medical equipment, medicine, pharmacy, bachelor's degree or above, or intermediate or above technical title 1, as the person in charge of quality;
2, with a high school diploma or above, as the quality of the administrator;
Third, for the second class of medical equipment business record Materials are required:
1, application form;
2, a copy of the business license;
3, the legal representative or person in charge of the enterprise, the person in charge of quality, identity, education, or proof of title;
4, the enterprise's business premises, warehouse address of the geographic location of the map, the floor plan; (indicating the actual site of the use of);
5, Commercial nature of the property certificate and red lease contract or site use certificate;
6, business facilities and equipment catalog;
7, enterprise business quality management system, work procedures and other file directory;
8, other supporting materials (our company to provide).
Four, processing time: 3-7 working days.
Expanded Information:
Class II Medical Devices
Class II Medical Devices are medical devices, the safety and effectiveness of which should be controlled. Including X-ray film machine, ultrasound, microscope, biochemistry instrument are class II medical devices. According to the "supervision and management of medical devices regulations" [2] Chapter IV, Article 30 provides: engaged in the operation of Class II medical devices, by the business enterprise to the municipal people's government where the municipal food and drug supervision and management department for the record and submit it to comply with the conditions of Article 29 of these regulations. (Article 29 to engage in the operation of medical devices, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices appropriate quality management system and quality management organizations or personnel.)