China’s NMPA has issued draft guidelines on medical device QMS audit for product registration. The draft Guideline for Inspection of Quality Management System for Medical Device Registration (Revision Draft for Comments) is open for comments by industry stakeholders until June 27, 2022.
This draft is a revision to the 2020 version.
Scope of Application
This guideline applies to the on-site audit of the Quality Management System (QMS) for Class II and Class III medical device registration carried out by the regulatory authorities.
Key Points on the On-site Audit
- Quality Management System principle
- Institution & people
- Plant, facilities and equipment
- File management
- Design and development
- Quality control
- Commissioned production
- Product authenticity
Research and development
For the situation of entrusted research and development (R&D), the applicant should have quality management measures for related activities. The applicant should sign a commissioned R&D agreement with the entrusted R&D institution, clearly stipulating the responsibilities of all parties, the content of R&D and related technical matters. The applicant should be responsible for the process and results of the commissioned R&D, as well as ensuring the reliability of data in the commissioned R&D process. The entrusted institution should comply with the requirements of the agreement to ensure that the R&D process is standardized, and that the data is true, accurate and traceable.
It is worth highlighting that the Guideline once promulgated will, for the first time, provide legal basis for commissioned R&D.
Where there is a situation of entrustment in the process of R&D or production, the applicant should clarify the departments and personnel responsible for guiding and supervising the quality management system of the entrusted enterprises. Applicants should:
- trace and monitor the whole process of R&D, production, storage and transportation as well as adverse event monitoring,
- maintain the continuous improvement of the quality management system,
- and implement the supervision of the entrusted enterprises.
Checklist of medical device QMS inspection items
A list of inspection items can be found in the appendix to the Guidelines. There are a total of 73 inspection items, of which 32 are key items and 41 are general items. The on-site audit team will make conclusions of “conformed”, “non-conformed” or “non-applicable” to each items separately.
How to submit comments on the medical device QMS audit for product registration guidelines
The deadline for comments is June 27, 2022. Cisema customers may submit their comments to their respective regulatory affairs project manager otherwise comments may be sent directly to email@example.com, and the subject of the email should be marked as “Comments on the Revision Draft of the Guideline for Inspection of Quality Management System for Medical Device Registration “.
By Grace and Victoria. If you require assistance in establishing a China conform medical device QMS or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods, contact Cisema.