China medical device quality and safety responsibilities have seen new proposals issued by the National Medical Products Administration (NMPA) recently. As part of the NMPA’s drive to ensure the quality and safety of medical devices in the market, it is proposing to strengthen the responsibilities of medical device registrants and filers, entrusted manufacturers and key personnel.
Important information
The proposed regulations list the duties and responsibilities required for manufacturers, businesses and third-party platforms involved in medical device trading services.
This document has detailed and comprehensive regulations on the requirements for key quality and safety posts of manufacturing enterprises, key quality and safety posts of operating enterprises, quality and safety management mechanism of enterprises, and performance guarantee mechanism of key quality and safety posts of enterprises in the responsibility supervision and management of medical device quality and safety subjects.
Summary of the proposed regulations on medical device quality and safety responsibilities for China
Scope of application
The following persons shall abide by this regulation when implementing the quality and safety responsibilities of medical devices:
- The main person in charge of the production enterprise
- The management representative
- The person in charge of the quality management department
- The main person in charge of operations
- The person in charge of quality and the quality management personnel
General requirements
Medical device registrants and filers are responsible for the safety and effectiveness of listed medical devices in accordance with the law, entrusted production enterprises are responsible for entrusted production activities, and operating enterprises are responsible for their own business operations.
Requirements for key positions of quality and safety in production enterprises
The main person in charge of the production enterprise shall be fully responsible for the quality and safety of medical devices in the enterprise, and establish and implement a long-term mechanism for the main body’s responsibility for the quality and safety of medical devices. The main person in charge of the enterprise shall perform duties including but not limited to the following:
- Organize the formulation of enterprise quality policy and quality goals;
- Ensure the human resources, infrastructure and working environment required for the effective operation of the quality management system;
- Organize and implement management reviews, regularly evaluate the operation of the quality management system, and continue to improve;
- Organize production in accordance with relevant laws, regulations, rules, production quality management specifications, as well as mandatory standards and product technical requirements.
Qualifications for management representatives
The main person in charge of the production enterprise shall appoint a management representative among the senior management personnel of the enterprise. The management representative shall be a full-time employee of the company where he/she works, and shall not work part-time in other companies, and shall at least meet the following conditions:
- Law-abiding, good professional ethics and no bad practice records.
- Familiar with and be able to correctly implement relevant laws, regulations, rules, norms and standards, and have received systematic quality management system knowledge training.
- Familiar with the quality management of medical device production, have the professional skills to guide and supervise the implementation of quality management standards for medical device production by various departments of the enterprise and the ability to solve practical problems.
- For the manufacture of Class II and Class III medical devices, the management representative shall, in principle, have a bachelor’s degree or above or an intermediate or above technical title in medical device related disciplines, and have at least 3 years of experience in quality management or production and technical management.
Responsibilities of the management representative
The management representative should be appointed and authorized by the main person in charge of the enterprise, and independently perform duties within the enterprise. When finding that there are quality and safety risks in medical device products, they should put forward veto opinions on the marketing of relevant products or suggestions to stop production activities. The management representative shall perform duties including but not limited to the following:
- Implement relevant laws, regulations, rules, specifications, mandatory standards and product technical requirements.
- Organize the establishment, implementation and maintenance of the enterprise’s medical device quality management system, and report the operation of the quality management system and improvement needs to the main responsible person of the enterprise.
- Ensure that medical devices meet the release requirements, and organize the information collection of product quality after marketing.
- Organize the self-examination of enterprises, the monitoring and reporting of medical device adverse events, and the recall of medical devices.
- Cooperate with the drug supervision and management department to carry out supervision and inspection, and organize relevant departments of the enterprise to rectify and correct the problems found in time as required.
Management requirements for management representatives
The main person in charge of the production enterprise shall sign a letter of authorization with the management representative, specifying the quality management responsibilities that the management representative shall perform and granting corresponding authority. The enterprise shall report to the local drug supervision and management department within 15 working days after confirming the management representative.
Qualifications for the person in charge of the quality management department
The person in charge of the quality management department shall be familiar with relevant laws, regulations, rules, norms and standards of medical devices, have practical experience and work skills in quality management, and have professional knowledge and work experience that match the products produced.
Responsibilities of the person in charge of the quality management department
The person in charge of the quality management department shall perform duties including but not limited to the following:
- According to the requirements of quality control procedures, correctly identify various quality control points and formulate management procedures.
- Ensure that the personnel in this department have received relevant training and mastered relevant theoretical knowledge and practical skills.
- Analyze, judge and handle the actual problems in quality management, and report the work to the management representative.
Requirements for key positions in operating enterprise quality and safety
- Responsibilities of the main person in charge:
- The main 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 specifications.
- Responsibilities of the person in charge of quality:
- The person in charge of the quality of the operating enterprise shall be responsible for the quality management of medical devices, and shall independently perform his/her duties. He/she shall have the right of adjudication on the quality management of medical devices within the enterprise, and shall bear the corresponding quality management responsibilities.
- Qualifications of the person in charge of quality:
- The person in charge of the quality of the Class III medical devices business enterprise shall have a medical device-related professional college degree or above or an intermediate professional technical title or above, and have 3 years or more of medical device business quality management work experience.
- Qualifications for quality managers:
- Among the quality management personnel of the IVD reagent business enterprise, at least one person should have the title of chief inspector, or have a college degree or above in laboratory related majors and have at least 3 years of work experience in laboratory related work. Among the quality management personnel of an enterprise that specializes in the transportation and storage of medical devices, at least 2 of them should have a college degree or above or a professional technical title at the intermediate level or above, and at least 3 years of medical device quality management experience.
Management mechanism of enterprise quality and safety
- Management requirements:
- Production enterprises and operating enterprises shall carry out medical device production and operation activities in strict accordance with the requirements of relevant laws, regulations, rules, and norms.
- Entrusted production management:
- Where a medical device registrant or a registrant entrusts the production of medical devices, the quality agreement and the entrustment agreement shall be signed by the main person in charge of the enterprise in accordance with the requirements of the guidelines for the quality agreement on entrusted production of medical devices formulated by NMPA, and the obligations and responsibilities that should be performed by the registrant and the registrant according to law shall not be transferred through the agreement. The entrusted medical device production shall not be entrusted again.
- Product Release Requirements:
- The production enterprise shall establish product release procedures to specify the product release conditions and the requirements for examination and approval. The registrant and the registrant shall establish product release procedures, 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 on the market shall not be entrusted to entrusted production enterprises.
- Corrective and preventive requirements:
- Production enterprises shall establish corrective and preventive procedures. The production enterprise shall investigate and analyze the product recall, adverse event monitoring, user complaints, enterprise self-inspection or unqualified supervision and sampling inspection, supervision and inspection results, internal and external audits, etc.
- Responsibility adjustment
- The production enterprise can adjust the responsibilities of the key personnel involved in quality and safety according to the actual needs, but it should ensure that the relevant laws, regulations, production quality management specifications and requirements are met.
- Scheduling requirements of production enterprises
- The main person in charge of the production enterprise shall regularly review the work reports of the management representative, study and schedule the quality and safety management of the enterprise and make records.
- Requirements for business enterprise consultation
- The main person in charge of the business enterprise shall regularly review the work report of the quality responsible person, conduct work consultation and summary on the quality and safety risks of the enterprise’s operation, make scheduling arrangements for key work, and form the memos of the medical device quality and safety risk consultation meeting.
Guarantee mechanism for performance of key positions in enterprise quality and safety
- Performance guarantee mechanism:
- The production enterprises and business enterprises shall establish and improve the job performance guarantee mechanism for personnel in key quality and safety positions, define their job responsibilities and conditions, provide training, authority and resources appropriate to their job responsibilities, and provide necessary guarantee for the full performance of personnel in key quality and safety positions.
- Description of key positions:
- Production enterprises and business enterprises shall formulate quality and safety key positions’ descriptions, define the main responsibilities of key quality and safety personnel, and specify the qualifications and required authorities of management representatives, quality directors, and heads of quality management departments.
- Training requirements
- Production enterprises and business enterprises shall, in accordance with the requirements of the quality management system, conduct pre job training and continuing education related to their responsibilities and work contents for personnel in key quality and safety posts, and establish training records.
- Performance requirements
- The management representative of the production enterprise, the person in charge of the quality management department, the person in charge of the quality of the operating enterprise and the quality management personnel shall be on duty and perform their duties.
- Due Diligence Disclaimer
- The management representative of the production enterprise, the person in charge of the quality management department, the person in charge of the quality of the operating enterprise, and the quality management personnel shall immediately report the potential risks to the quality and safety of medical devices according to the procedures. The enterprise shall take risk control measures in a timely manner according to law, and the relevant reports shall be recorded and kept.
- Incentives and penalties
- Encourage enterprises to establish incentive mechanisms for personnel in key quality and safety positions, and commend and reward those who have achieved remarkable results.
