Legal subjectivity:
1. Having a quality management organization or full-time quality management personnel that is commensurate with the business scale and business scope. Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state; 2. Have a relatively independent business location that is commensurate with the business scale and business scope; 3. Have storage conditions that are commensurate with the business scale and business scope, including having Storage facilities and equipment required by the characteristics of medical device products; 4. A sound product quality management system should be established, including procurement, incoming goods inspection and acceptance, warehousing and storage, outbound review, quality tracking system and adverse event reporting system, etc.; 5. It should be equipped with the corresponding The ability to provide technical training and after-sales service suitable for the medical device products operated, or agree to have a third party provide technical support. Legal objectivity:
Article 3 of the "Measures for the Supervision and Administration of Medical Device Operations"
The State Food and Drug Administration is responsible for the supervision and administration of medical device operations nationwide. The food and drug regulatory authorities at or above the county level are responsible for the supervision and management of medical device operations in their respective administrative regions.
The superior food and drug regulatory department is responsible for guiding and supervising the lower-level food and drug regulatory departments to carry out the supervision and management of medical device operations.
Article 4
According to the degree of risk of medical devices, medical device operations shall be subject to classified management.
The operation of Class I medical devices does not require licensing and registration, the operation of Class II medical devices is subject to filing management, and the operation of Class III medical devices is subject to licensing management.