Conditions for starting a medical device operating enterprise: 1. Personnel: 1. The full-time quality management personnel of the third category medical device operating enterprise should have a college degree or above or an intermediate professional title or above;
2. The third-category medical device operating enterprise shall have a capital of not less than 1 million yuan
3. The quality inspection personnel of the third-category medical device operating enterprise shall have a college degree or above or an intermediate professional title or above; 4. The business involves retailing household therapeutic products Enterprises that produce products or Class III implantable devices should be staffed by personnel with certain medical technical qualifications.
2. Business premises
1. Business premises: Generally, the area used by enterprises is not less than 40 square meters. Residential buildings cannot be used as business premises of enterprises; retail operating enterprises must be storefront buildings. ;
2. Warehousing conditions: Generally, the area used by enterprises is not less than 20 square meters, and residential buildings cannot be used as storage places for enterprises;
3. Operating single-use sterile and plant-based products Enterprises that produce special medical device products such as those that can be inserted into the body must have self-managed warehouses, and the storage conditions should comply with the requirements of product standards. Details can be found on Frida’s official website.