Medical device QMS verification guidelines have been updated to assist with the China medical device registration process.
The National Medical Products Administration (NMPA) issued a revision of the Guidelines for the Verification of the Quality Management System for the Registration of Medical Devices in October 2022.
Scope of the medical device QMS verification guidelines
The guidelines apply to the verification of the medical device quality management system carried out by the NMPA for Class II and Class III medical devices. The guidelines came into force on October 10, 2022 and replace the previous version (No.19-2020).
The guidelines contain a total of 73 items to be verified, including 32 key items and 41 general items. The verification will be conducted point by point. Each point will be judged to be compliant, non-compliant or not applicable. Passing or failing the verification of the medical device QMS in order to register the medical device in China is determined according to the number of compliant and non-compliant points and their criticality.
Medical device manufacturers intending to register their products in China should refer to the new guidelines; four sections are of importance during the registration process for Class II and Class III medical devices.
- quality management system
- registration verification requirements
- self-inspection verification requirements
- entrusted activity inspection, extended inspection requirements
Medical Device Quality Management System Requirements
The registration applicant shall, in accordance with the requirements of the Quality Management Practice for the Manufacture of Medical Devices and its appendices, establish a medical device Quality Management System appropriate to the process of product realization based on scientific knowledge, experience and the principles of risk management. It shall include the commissioning of production (if any), clinical evaluation (including clinical trials), etc., to ensure its effectiveness in the process of managing the whole life cycle of the medical device. The QMS shall be verified as part of the registration process and will need to satisfy the registration verification requirements.
Registration verification requirements
Verification of the medical device QMS shall be undertaken in conjunction with the registration declaration data focusing on the:
- design and development,
- procurement,
- production management, and
- quality control related to product development and production.
Product authenticity verification should be comprehensive and objective.
Self-inspection verification requirements
For the submission of self-inspection reports, the applicant’s medical device quality management system and capabilities should be verified item by item in accordance with the “Regulations on Self-inspection of Medical Device Registration”, combined with the technical requirements of the submitted products.
Requirements for inspection of entrusted activities and extended inspection
For applicants with design and development, product production and other activities entrusted to other enterprises, the scope of verification shall cover entrusted R&D and entrusted production activities. If necessary, extended inspection shall be carried out on other units providing products or services for medical device R&D and production activities. The inclusion of outsourced R&D activities for inspection is new to this edition of the guidelines.
Further information
If you need advice on how these new guidelines apply to the registration of your medical device in China, or information on registering medical devices in China please contact us.
