I. Personnel:
1. Class III medical device business enterprise quality full-time management personnel should have a college degree or above, or intermediate or above title;
2. Class III medical device business enterprise is not less than 1 million yuan
3. Class III medical device business enterprise quality inspection personnel should have a College degree or above, or intermediate or above; 4. Business involving retail household therapeutic products or Class III implantable devices should be equipped with certain medical and technical qualifications.
Two, business premises
1. Business premises: general business use area of not less than 40 square meters, residential buildings can not be used as business premises; retail business enterprises must be front rooms;
2. Warehousing conditions: general business use area of not less than 20 square meters, residential buildings can not be used as a business warehousing premises;
3. One-time use of sterile, implantable and other special medical device products, enterprises must have their own management of the warehouse, warehousing conditions should be in line with the requirements of the provisions of the product standard.
Freda medical device consulting organization provides.