Announcement of the State Food and Drug Administration on Issuing the "Regulations on the Supervision and Management of Enterprises' Implementation of the Main Responsibility for Quality and Safety of Medical Devices" (No. 124 of 2022)

In order to supervise and urge medical device registrants and registrants to implement the main responsibility for the quality and safety of medical devices, and strengthen the implementation of the responsibilities of personnel in key positions of quality and safety in medical device production and operation enterprises, in accordance with the Regulations on the Supervision and Management of Medical Devices, the Measures for the Supervision and Management of Medical Device Production, the Measures for the Supervision and Management of Medical Device Operation, and other regulations, The State Food and Drug Administration has organized the formulation of the "Regulations on the Supervision and Management of Enterprises' Implementation of the Main Responsibility for Quality and Safety of Medical Devices", which is now issued and will come into effect from March 1, 2023.

Hereby announced.

Attachment

Enterprises implement the main responsibility for the quality and safety of medical devices

Supervision and Management Regulations

Chapter 1 General Provisions

Article 1: In order to urge medical device registrants and recorders to fulfill their main responsibilities for the quality and safety of medical devices, and to strengthen the implementation of the responsibilities of key personnel in the quality and safety positions of medical device registrants, recorders, entrusted production enterprises (hereinafter referred to as "production enterprises") and operating enterprises, This regulation is formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of Medical Device Production, the Measures for the Supervision and Administration of Medical Device Operation, the Quality Management Standards for Medical Device Production, and the Quality Management Standards for Medical Device Operation.

Article 2: Within the territory of the People's Republic of China, medical device production and operation enterprises shall implement the quality and safety responsibility behavior of medical devices and their supervision and management in accordance with the law, and this provision shall apply.

Article 3: The registrant and registrant of medical devices shall be responsible for the safety and effectiveness of listed medical devices in accordance with the law, the entrusted production enterprise shall be responsible for the entrusted production behavior, and the operating enterprise shall be responsible for its own business behavior.

Enterprises should establish quality and safety critical positions in accordance with the principle of "consistent rights and responsibilities, individual responsibilities, appropriate job selection, due diligence, exemption from responsibility, and based rewards and punishments", and equip personnel in quality and safety critical positions that are suitable for the nature of production or business products and the size of the enterprise. Necessary resources and institutional guarantees should be provided for their performance to ensure that personnel in quality and safety critical positions fully perform their duties.

Chapter 2 Requirements for Key Quality and Safety Positions in Production Enterprises

Article 4: Personnel in key positions of quality and safety in production enterprises generally include the legal representative and main responsible person of the enterprise (hereinafter referred to as the "enterprise responsible person"), management representative, and head of the quality management department. The enterprise head is the top management, the management representative is the senior management, and the head of the quality management department is generally the middle level management.

Production enterprises can add positions such as Deputy General Manager of Quality and Quality Director based on actual needs, while clarifying the responsibilities of each position mentioned in the preceding paragraph.

Article 5: The person in charge of a production enterprise shall be fully responsible for the quality and safety of its medical devices, and establish and implement a long-term mechanism for the main responsibility of medical device quality and safety. The person in charge of the enterprise shall support and ensure that management representatives, quality management department heads, and other personnel carry out medical device quality and safety management work in accordance with the law; Before making major decisions related to the quality and safety of medical devices, it is necessary to fully listen to the opinions and suggestions of management representatives, quality management department heads, and other personnel. For the discovered quality and safety hazards of medical devices, it is necessary to organize research and propose disposal measures to promptly eliminate the risks and hidden dangers.

The person in charge of the enterprise shall fulfill the following responsibilities, including but not limited to:

（1） Organize the formulation of the company's quality policy and quality objectives;

（2） Ensure the human resources, infrastructure, and work environment required for the effective operation of the quality management system;

（3） Organize and implement management reviews, regularly evaluate the operation of the quality management system, and continuously improve it;

（4） Organize production in accordance with relevant laws, regulations, rules, production quality management standards, as well as mandatory standards and product technical requirements.

Article 6: The person in charge of a production enterprise shall appoint a management representative among the top management personnel of the enterprise. The management representative should be a full-time employee of the company and meet at least the following conditions:

（1） Comply with laws and regulations, possess good professional ethics, and have no negative employment records.

（2） Familiar with and able to correctly implement relevant laws, regulations, rules, norms, and standards, and have received systematic quality management system knowledge training.

（3） Familiar with the quality management of medical device production, possessing the professional skills to guide and supervise the implementation of medical device production quality management standards by various departments of the enterprise in accordance with regulations, and the ability to solve practical problems.

（4） For the production of Class II and Class III medical devices, the management representative should, in principle, have a bachelor's degree or above in a medical device related field or an intermediate or above technical title, and have at least 3 years of experience in quality management or production and technical management;

For the production of Class I medical devices, the management representative should in principle have a college degree or above, and have 3 years or more of work experience in medical device production enterprises.

A management representative who has 5 years or more of experience in medical device quality management or production and technical management, is familiar with the product, production and quality management situation of the enterprise, and has been proven to have good performance ability through practice can appropriately relax the requirements for relevant education and professional titles.

After taking office, management representatives should continue to strengthen knowledge updates, actively participate in learning and training activities related to the enterprise's quality management system, and continuously improve their quality management level.

Article 7: The management representative shall be appointed and authorized by the person in charge of the enterprise, and shall independently perform its duties within the enterprise. When it is found that there are quality and safety risks to the product, it shall propose a rejection opinion for the relevant product launch or a suggestion to stop production activities.

The management representative shall fulfill the following responsibilities, including but not limited to:

（1） Implement relevant laws, regulations, rules, specifications, mandatory standards, and product technical requirements.

（2） Organize the establishment, implementation, and maintenance of the enterprise quality management system, and report the operation status and improvement needs of the quality management system to the person in charge of the enterprise.

（3） Ensure that the product meets the release requirements and organize the collection of information on product quality after launch.

（4） Organize and carry out enterprise self inspection, adverse event monitoring and reporting, medical device recall, and other work.

（5） Cooperate with the drug supervision and management department to carry out supervision and inspection, and organize relevant departments of the enterprise to promptly rectify any problems found according to requirements.

Article 8: The person in charge of a production enterprise shall sign an authorization letter with the management representative, clarifying the quality management responsibilities that the management representative shall fulfill and granting corresponding authority. Enterprises shall report to the local drug regulatory department within 15 working days after determining the management representative.

Enterprises should establish and improve relevant management systems and assessment mechanisms for management representatives, provide necessary conditions for them to fulfill their duties, and ensure that they are not unduly interfered with by internal factors of the enterprise when fulfilling their duties. For management representatives who cannot effectively perform their duties, the person in charge of the enterprise shall immediately perform their duties on their behalf, or designate personnel who meet the requirements of Article 6 of these regulations to perform their duties as management representatives, and determine and appoint a new management representative within 30 working days.

Article 9: Production enterprises shall establish a quality management department and appoint a person in charge of the quality management department. The head of the quality management department should be familiar with the relevant laws, regulations, rules, specifications, and standards of medical devices, have practical experience and work skills in quality management, and have professional knowledge and work experience that matches the products produced.

Smaller scale production enterprises can have their management representatives serve as the head of the quality management department according to the actual situation.

The person in charge of the quality management department and the person in charge of the production management department shall not concurrently serve each other.

Article 10: The head of the quality management department shall fulfill the following responsibilities, including but not limited to:

（1） According to the requirements of quality control procedures, correctly identify various quality control points and develop management procedures.

（2） Ensure that personnel in this department receive relevant training and master relevant theoretical knowledge and practical operational skills.

（3） Analyze, judge, and handle practical issues in quality management.

Chapter 3 Requirements for Key Quality and Safety Positions in Operating Enterprises

Article 11 Personnel in key positions of quality and safety in operating enterprises include enterprise leaders, quality leaders, and quality management personnel. The enterprise leader is the top management, and the quality leader is the senior management or the head of the quality management organization.

Article 12: The person in charge of the operating enterprise shall be fully responsible for the quality and safety of the medical devices of the enterprise, provide necessary conditions, ensure that the quality responsible person and quality management personnel effectively perform their duties, and ensure that the enterprise operates medical devices in accordance with relevant laws, regulations, rules, and business quality management standards; Before making major decisions related to the quality and safety of medical devices, it is necessary to fully listen to the opinions and suggestions of the quality responsible person and quality management personnel. For any quality and safety hazards discovered by the enterprise, it is necessary to organize research and propose disposal measures to eliminate them in a timely manner.

Article 13: The quality manager of the operating enterprise shall be responsible for the quality management of medical devices and shall independently fulfill their responsibilities. They shall have the power to make judgments on the quality management of medical devices within the enterprise and bear corresponding quality management responsibilities.

Article 14: The quality manager of the third category medical device operating enterprise shall have a college degree or above in medical device related majors or an intermediate or above professional technical title, and have 3 years or more of experience in medical device operation quality management.

Article 15: Operating enterprises shall be equipped with quality management personnel suitable for their business scope and scale. Quality management personnel shall have relevant professional qualifications and professional titles, and fulfill the responsibilities stipulated in the quality management standards for medical device operation.

Among the quality management personnel of in vitro diagnostic reagent trading enterprises, at least one person should have the title of supervising laboratory technician; Or have a college degree or above in a laboratory related major (including laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, medical devices, etc.) or an intermediate or above professional technical title, and have 3 years or more of work experience in laboratory related work.

At least 2 quality management personnel from enterprises specialized in providing medical device transportation and storage services should have a college degree or above or an intermediate or above professional technical title, and should have at least 3 years of experience in medical device quality management.

Chapter 4 Enterprise Quality and Safety Management Mechanism

Article 16: Production and operation enterprises shall strictly comply with relevant laws, regulations, rules, norms and other requirements to carry out medical device production and operation activities. Personnel in key quality and safety positions should fully fulfill their job responsibilities, maintain the continuous and effective operation of the quality management system, and ensure that the entire process of medical device production and operation continues to comply with the requirements of medical device production and operation quality management standards.

Article 17: If a medical device registrant or registrant entrusts production, they shall sign a quality agreement and commission agreement in accordance with the quality agreement guidelines for medical device entrusted production formulated by the National Drug Administration, and shall not transfer the obligations and responsibilities that should be fulfilled by the registrant or registrant according to law through the agreement. Before commissioning production, the management representatives of the medical device registrant and registrant shall organize an evaluation of the quality assurance and risk management capabilities of the commissioned production enterprise; After commissioning production, regular on-site audits of the quality management system of the commissioned production enterprise should be organized to ensure effective connection between the quality management systems of both parties.

The entrusted production enterprise shall actively accept the review and supervision of the registrant and registrant, and promptly take corrective and preventive measures to implement its rectification requirements. Products entrusted for production shall not be entrusted for production again.

Article 18: Production enterprises shall establish product release procedures, clarify product release conditions and review and approval requirements.

The registrant and registrant shall establish product release procedures for marketing, and the head of the quality management department shall organize the review of the production process records and quality inspection results of medical devices. The release of products for market launch shall not be entrusted to entrusted production enterprises.

The entrusted production enterprise shall establish production release procedures, and the head of the quality management department shall organize an audit of the medical device production process and inspect the products.

Article 19: Production enterprises shall establish procedures for corrective and preventive measures.

Production enterprises should investigate and analyze the monitoring of adverse events, user complaints, enterprise self inspection or supervision sampling, supervision and inspection, internal and external audits, etc. For discovered problems, a corrective action program should be initiated, and the management representative or quality management department head should organize relevant departments to study and analyze the causes of the problems, take effective measures, and prevent the recurrence of related problems.

For potential problems, enterprises should initiate preventive action procedures, study the causes of potential problems, take effective measures to prevent problems from occurring.

Article 20: Production enterprises may adjust the responsibilities of personnel in key quality and safety positions referred to in Articles 17, 18, and 19 according to actual needs, but shall ensure compliance with relevant regulations, rules, production quality management standards, and Chapter 2 of these regulations.

Article 21: The person in charge of a production enterprise shall listen to the work report of the management representative at least once a quarter, review and analyze the production situation and quality and safety management situation of the enterprise, study the key work of risk prevention and control, make scheduling arrangements, and form scheduling records.

Article 22: The person in charge of the operating enterprise shall listen to the work report of the quality manager at least once a quarter, conduct work discussions and summaries on the quality and safety risks of the enterprise's operation, make scheduling arrangements for key work, and form the minutes of the medical device quality and safety risk meeting.

Chapter 5 Performance Guarantee Mechanism for Key Positions of Enterprise Quality and Safety

Article 23 Production and operation enterprises shall establish and improve a mechanism for ensuring the performance of personnel in key quality and safety positions, clarify job responsibilities and qualifications, provide training, permissions, and resources that are suitable for job responsibilities, and provide necessary guarantees for the full performance of personnel in key quality and safety positions.

Article 24 Production and operation enterprises shall formulate quality and safety key job descriptions, clarify the main responsibilities of personnel in quality and safety key positions, and specify the job qualifications and required authorities of management representatives, quality leaders, and quality management department heads.

Article 25 Production and operation enterprises shall, in accordance with the requirements of the quality management system, provide pre job training and continuing education related to their responsibilities and work content for personnel in key positions of quality and safety, and establish training records. The training content should include relevant laws and regulations, professional knowledge and skills of medical devices, quality management systems, etc.

Article 26: Management representatives of production enterprises, heads of quality management departments, and quality managers and quality management personnel of operating enterprises shall be on duty and fulfill their job responsibilities.

Enterprises should record the appointment, adjustment, and responsibility fulfillment of personnel responsible for key quality and safety positions in accordance with the requirements of the quality management system, and archive them for future reference.

Article 27: If the management representative of the production enterprise, the head of the quality management department, the quality head of the operating enterprise, and the quality management personnel discover potential risks to the quality and safety of medical devices, they shall immediately report according to the procedures. Enterprises should take timely risk control measures in accordance with the law, and relevant reports should be recorded and saved.

If the enterprise and the person in charge of the enterprise fail to adopt the opinions and suggestions proposed by the above-mentioned personnel without justifiable reasons, resulting in the occurrence of medical device quality and safety violations, the enterprise and the person in charge of the enterprise shall be punished in accordance with the law, and the person in charge of the medical device quality and safety position who fulfills their duties in accordance with the law shall not be punished in accordance with the law.

Article 28: Encourage enterprises to establish incentive mechanisms for personnel in key quality and safety positions, and commend and reward those who have achieved significant work results.

If personnel in key positions of quality and safety fail to fulfill their responsibilities according to regulations, resulting in medical device quality and safety accidents, the enterprise shall hold them accountable for their work.

If the drug regulatory department discovers during supervision and inspection that personnel in key quality and safety positions have not fulfilled their duties as required, it shall require the enterprise to rectify within a specified period of time; If a serious illegal behavior is found in an enterprise, the person in charge, directly responsible supervisors, and other responsible personnel of the enterprise shall be fined or prohibited from engaging in employment in accordance with the provisions of the "Regulations on the Supervision and Administration of Medical Devices".

Chapter 6 Supplementary Provisions

Article 29: E-commerce platform operators providing services for online transactions of medical devices shall comply with the requirements of these regulations for operating enterprises.

Article 30: These regulations shall come into effect from March 1, 2023.