China post-market surveillance regulatory research meeting – 2022 summary report

China post-market surveillance regulations for medical devices in 2022 were being reviewed in a meeting carried out by the National Medical Products Administration (NMPA) on December 8, 2022.

Work report on laws and regulations in different provinces and cities

During the meeting, the provincial medical products administration units provided a summary report on each respective regulatory research work carried out for supervision of medical device production, operation, network sales, sampling inspection, adverse event monitoring and case investigation in 2022:

• The Medical Products Administration of Zhejiang Province took the lead in drafting documents such as “Opinions on Strengthening the Collaborative Supervision of Cross-Regional Commissioned Production of Medical Devices” to continuously enrich the production supervision system and promote the implementation of responsibilities of all parties.
• The Medical Products Administration of Jilin Province took the lead in completing the research on third-party logistics of medical devices, and provided support for the release of the “Appendix of Medical Device Operation Quality Management Standards: Quality Management of Enterprises Specializing in Medical Device Transportation and Storage Services”.
• The Medical Products Administration of Shandong Province conducts research on the investigation, evaluation and recall of products that do not meet the requirements of sampling inspection, improves the disposal procedures of technical means of supervision and sampling inspection, and promotes the improvement of work efficiency.
• The Medical Products Administration of Peking enriched the basis of adverse event monitoring and evaluation from the aspects of regulations, technology and cases.
• The Medical Products Administration of Guangdong Province investigated the implementation of laws and regulations of third-party platform enterprises and online sales enterprises of medical device online trading services, and put forward relevant suggestions on the difficulties, pain points and obstacles of grassroots supervision.
• The Medical Products Administration of Hunan Province investigated the implementation of rules, norms and systems in the use process and put forward suggestions for revision and improvement.
• The Medical Products Administration of Jiangsu Province compared the new models such as cross-regional commissioned production under the full implementation of the registrant system, and studied how to carry out supervision and law enforcement more effectively in practice.

Further information

Click here to read the full announcement of the meeting held to review the medical device post-market surveillance regulations in 2022.

If you would like to learn more about the China post-market surveillance requirements or how we can support you to comply with the requirements for selling medical devices in China, please contact us.

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