1 In order to strengthen the quality management of medical devices, standardize the business behavior of medical devices, and ensure the safety and effectiveness of medical devices, this specification is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Devices.

2. Medical device enterprises should take effective quality control measures in the procurement, acceptance, storage, sales, transportation and after-sales service of medical devices to ensure the quality and safety of products in the process of operation.

3. The person in charge of enterprise quality is the person in charge of medical device quality management, who shall independently perform his duties, have the right of adjudication on the internal medical device quality management, and bear the corresponding quality management responsibilities.

The quality management organization or quality management personnel of the extended information enterprise shall perform the following duties:

1, organize the formulation of quality management system, guide and supervise the implementation of the system, and check, correct and continuously improve the implementation of the quality management system;

2, responsible for collecting the relevant provisions of laws and regulations related to medical device management, the implementation of dynamic management;

3, urge the relevant departments and post personnel to implement the laws and regulations of medical devices and this specification;

4. Be responsible for the qualification review of medical device suppliers, products and buyers;

5, responsible for the confirmation of unqualified medical devices, supervise the handling of unqualified medical devices;

6, responsible for the investigation, handling and reporting of medical device quality complaints and quality accidents.

Baidu Encyclopedia-Quality Management Standard for Medical Device Management