The qualifications required for the operation of medical devices:
1. with the scope of business and the scale of operation of the quality management organization or quality management personnel, quality management personnel should have a state-recognized professional qualifications or titles;
2. with the scope of business and the scale of operation of the business, storage space;
3. With the business scope and scale of operation of the storage conditions, all entrusted to other medical device business enterprise storage can not set up a warehouse;
4. With the operation of medical devices appropriate quality management system;
5. With the operation of medical devices appropriate professional guidance, technical training and after-sales service capacity, or agreed to provide technical support by the relevant organizations.
6.
Operation of medical devices, the need for corporate nature of the enterprise, in accordance with the degree of risk of medical devices, medical devices business implementation of classification management.
Engaged in medical device business activities, 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 and quality management system and quality management organizations or personnel. The operation of Class I medical devices do not need business license and record; engaged in the operation of Class II medical devices, should be filed with the municipal food and drug regulatory departments where the district; engaged in the operation of Class III medical devices, the business enterprise shall apply for a license to the municipal people's government of the municipal food and drug supervision and management department, by the municipal people's government of the municipal government of the district review and approval of the food and drug supervision and management department and issue a medical device business license. Medical device manufacturers to sell their own production of medical devices, do not need to apply for business license or record. Enterprises operating Class II medical devices need to have the above qualifications, but if they are engaged in the operation of Class III medical devices, in addition to the above conditions, they should also have a computerized information management system that meets the requirements of quality management of medical device business, to ensure that the products operated can be traced. And the third class medical devices on the quality of the enterprise responsible for higher requirements, the quality of the business of the third class medical device enterprise responsible for quality should have a medical device related professional college degree or intermediate or above professional and technical title, at the same time, should have more than 3 years of experience in medical device business quality management.
Legal basis：
《Medical Device Business License Management Measures》 Article 2 《Medical Device Business License》issuance, renewal, change and supervision and management of the application of these measures.
Article 3 The operation of the second and third class of medical devices should hold a "medical device business enterprise license", but in the circulation process through routine management can ensure its safety and effectiveness of a few second class of medical devices can not apply for a "medical device business enterprise license". Do not need to apply for a "medical device business license" of the second class of medical devices by the State Food and Drug Administration to develop a product list.
Article VI to apply for a "medical device business license" shall have the following conditions:
(a) with the scale and scope of operation of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized relevant professional qualifications or titles;
(ii) with the scale and scope of operation of relatively independent premises;
(iii) with the scale and scope of operation of storage conditions, including storage facilities and equipment in line with the requirements of the characteristics of the medical device products;
(iv) should be Establish and improve product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and reporting system of adverse events;
(e) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.