1. What is the background of the Regulations on Supervision and Management of Enterprises' Implementation of the Main Responsibility for Quality and Safety of Medical Devices (hereinafter referred to as "the Regulations")?
After years of efforts, medical device manufacturing and operating enterprises have established quality management systems, and the concept of risk management is widely accepted and practiced. However, there are still some enterprises that fail to understand systematically and thoroughly the key responsibilities of quality and safety, and the responsibilities of quality and safety management are not effectively implemented in place. In order to further implement the requirements of the Regulations for the Supervision and Administration of Medical Devices, the Supervision and Administration of Medical Device Production, and the Supervision and Administration of Medical Device Operation, to urge medical device registrants and filers to implement the main responsibility for quality and safety, and to strengthen the implementation of the responsibilities of key positions of quality and safety in medical device production and operation enterprises, the State Drug Administration, after research and demonstration and extensive consultation with all parties, formulated and issued the Provisions", since March 1, 2023 shall come into force.
2. What are the main contents of the Regulations?
The Regulations consist of six chapters and 30 articles, mainly covering three aspects:
First, the key positions of quality and safety requirements, clarify the key positions of production enterprises, including the legal representative and the main person in charge of the enterprise (hereinafter referred to as "the head of the enterprise"), the manager's representative, the head of the quality management department, operating enterprises in charge of key positions of quality and safety, including the head of the enterprise, the person in charge of quality, quality The key positions in charge of quality and safety in operating enterprises include the person in charge of the enterprise, the person in charge of quality, and the quality management personnel, refining the duties and conditions of employment of each position.
The second is the quality and safety management requirements, which stipulates the quality and safety management scheduling and risk consultation system, refines the management requirements of key links such as entrusted production management and product release, and specifies the personnel responsible for each link.
Thirdly, the performance guarantee mechanism requires enterprises to formulate key job descriptions for quality and safety and to provide pre-service training and continuing education for relevant personnel, stipulates that the manager's representative of the production enterprise, the person in charge of the quality management department and the person in charge of the quality of the operating enterprise and the quality management personnel should be on duty, and specifies the due diligence exemption system and the reward and punishment system of the enterprise for relevant personnel.
3. How do the Regulations relate to the existing regulations and institutional documents in force?
Considering the continuity of policies, most of the provisions of the Regulations are the refinement of the requirements of existing rules, regulations and codes, and a few provisions are the generalization of the requirements of the guideline documents. At the same time, according to the development of the industry, individual articles have been fine-tuned to the provisions of the Code of Practice for the Quality Management of Medical Devices and the Guidelines for the Management of Managerial Representatives of Medical Device Manufacturers (hereinafter referred to as the "Guidelines for Managerial Representatives"), for example, the Guidelines for Managerial Representatives require that the managerial representatives of Class II medical device manufacturers should have a university degree or above in a medical device related field or a junior level or above. The Regulations have been amended to "have a bachelor's degree or above in a medical device related field or an intermediate or above technical title".
For the above-mentioned provisions that are different from the provisions of the existing medical device production and operation-related normative documents and guidelines, the Regulations shall be implemented in accordance with the requirements of the Regulations after the implementation of the Regulations. In the next step, the medical device production and operation quality management norms under revision will dovetail with the Regulations, and the Guidelines for Managerial Representatives issued in September 2018 will also be revised in due course.
Content source: State Medical Products Administration
