I. Personnel:
1. Full-time quality management personnel of medical device enterprises of Category III shall have college degree or above or intermediate title or above;
2. The third category of medical device enterprises shall not be less than 6.5438+0 million yuan.
3. The quality inspectors of third-class medical device enterprises should have college education or intermediate titles; 4 enterprises engaged in the retail of domestic therapeutic products or three types of implanted devices should be equipped with personnel with certain medical qualifications.
Second, the business premises
1. business premises: the use area of general enterprises is not less than 40 square meters, and residential buildings cannot be used as business premises; Retail enterprises must be facade houses;
2. Storage conditions: the use area of general enterprises is not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises;
3. Enterprises engaged in disposable aseptic, implanted and other special medical devices must have their own warehouses, and the storage conditions should meet the requirements of product standards.
Provided by Frieda Medical Device Consulting Agency.