In vitro diagnostic reagent business enterprise personnel what are the requirements?

1, in order to strengthen the quality management of medical device business, standardize the management of medical device business behavior, to ensure the safety and effectiveness of medical devices, according to the "Supervision and Administration of Medical Devices Regulations" and "supervision and management of medical devices" and other laws and regulations, the development of this specification.

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

3, the enterprise quality responsible for the quality management of medical devices, should be independent to fulfill their duties, within the enterprise on the quality management of medical devices have the right to rule, bear the corresponding quality management responsibility.

Enterprise quality management organization or quality management personnel shall perform the following duties:

1, the organization to develop quality management system, guidance, supervision of the implementation of the system, and the implementation of the quality management system for inspection, correction and continuous improvement;

2, responsible for the collection of medical devices related to the operation of the relevant laws, regulations and other relevant provisions, the implementation of the Dynamic management;

3, supervise the relevant departments and positions in the implementation of medical device regulations and rules and this specification;

4, responsible for medical device suppliers, products, purchasers qualification audit;

5, is responsible for unqualified medical devices to confirm the process of unqualified medical devices to supervise the process of handling;

6, is responsible for the quality of medical devices Complaints and quality incident investigation, processing and reporting.

Baidu Encyclopedia - Medical Device Business Quality Management Standard