This kind of business license shall meet the following conditions. 1. It has business premises and warehouses suitable for its business scope, and has specific area requirements. 2. There are on-the-job personnel recognized by the state who are related to operating products. 3. There should be technical personnel with technical secondary school education or above who are related to operating products. 4, with the management of medical devices to adapt to the quality management system.
Legal objectivity:
Article 3 of the Measures for the Administration of Medical Device Business License shall hold a Medical Device Business License for operating Class II and Class III medical devices, but a few Class II medical devices that can ensure their safety and effectiveness through routine management in the circulation process may not apply for a Medical Device Business License. The catalogue of Class II medical device products that do not need to apply for the Medical Device Business License shall be formulated by the State Food and Drug Administration of the United States.