China medical device quality and safety responsibility regulations come into force on March 1, 2023.
At the end of last year, the National Medical Products Administration (NMPA) issued the final version of the Regulations on Company Responsibility for Medical Device Quality and Safety (no. 124-2022).
The China medical device quality and safety responsibility regulations strengthen the implementation of the responsibilities of personnel in key positions in the quality and safety of medical device production and operating enterprises.
These regulations lay out specific requirements for the key positions of quality and safety, the quality and safety management mechanism, and the guarantee mechanism for the performance of duties of key positions of quality and safety in medical device production and operating enterprises.
Requirements for key positions in quality and safety
It is clarified that the personnel in the key positions of quality and safety in the production enterprise include:
- the legal representative and main person in charge of the enterprise
- the management representative
- the person in charge of the quality management department
It is also clarified that personnel in the key positions of quality and safety in the operating enterprise include:
- the person in charge of the enterprise
- the person in charge of quality
- the quality management personnel
Responsibilities and qualifications for each position are detailed.
Quality and safety management requirements
It stipulates the quality and safety management scheduling and risk consultation system, refines the management requirements of key activities such as entrusted production management and product release, and specifies the responsible personnel for each activity.
Guarantee mechanisms for the performance of duties
Enterprises are required to formulate quality and safety key job descriptions and provide pre-job training and continuing education for relevant personnel. It is stipulated that representatives of production enterprise managers, heads of quality management departments, and quality managers and quality management personnel of operating enterprises should be on-the-job. The due diligence exemption system and the company’s reward and sanction system for relevant personnel are clarified.
Qualifications of quality management personnel
Specific examples were given of the types of laboratory science degrees and experience that quality management personnel could have including laboratory science, biomedical engineering, biochemistry, immunology, genetics, pharmacy, biotechnology, clinical medicine, medical devices.
It is also specified that this professional or technical experience must be at or above the intermediate management level.
Entrusted production management
It is now specified that an on-site audit of the quality management system of the entrusted production enterprise should be organized regularly to ensure the effective connection of the quality management systems of both parties.
The entrusted production enterprise shall actively accept the examination and supervision of the registrant, and that they undertake corrective and preventive measures in a timely fashion to implement any rectification requirements otherwise the entrusted products are not to be commissioned again.
Scheduling requirements of production enterprises
New requirements have been added:
The person in charge of the production enterprise shall refer to the work report of the management representative at least once a quarter. This involves reviewing and analyzing the production and quality and safety management of the enterprise, studying the key work of risk prevention and control, making scheduling arrangements, and creating scheduling records.
New requirements have been added for medical device operating companies:
The person in charge of the operating enterprise shall refer to the work report of the person in charge of quality at least once a quarter. This shall include carrying out work consultation and a summary on the quality and safety risks of the enterprise’s operation, making scheduling arrangements for key work, and writing up the minutes of the medical device quality and safety risk consultation meeting.
Due Diligence Disclaimer
Personnel who receive sanctions have been clarified:
If the enterprise and the person in charge of the enterprise fail to adopt the opinions and suggestions put forward by the above 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 who fails to take the opinions and suggestions put forward by the above personnel without justifiable reasons shall not be punished in accordance with the law.
Click here to read in full the China medical device quality and safety responsibility regulations.
Click here to read the draft proposal for comments of the China medical device quality and safety responsibility regulations.
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