China Update: Opinions to Further Improve Classification Management of Medical Devices and More

China’s medical device regulators have announced a series of updates, including publishing new guidelines, consultation of draft opinions on further strengthening supervision of entrusted production, and opinions released to further improve classification management of medical devices.

CMDE publishes various guidelines and review points

The Center for Medical Device Evaluation (CMDE) has published several new guidance documents, including the Registration Review Guidelines for Clinical Evaluation of the Same Type of Ventilator, Registration Review Guidelines for Continuous Glucose Monitoring Systems (2023 Revision), and the Technical Guidelines for Benefit-Risk Determination of Medical Device Products (2023 Revision) (links in Chinese). The CMDE also released Announcement No. 23 of 2023 to publish various review points for the performance evaluation and clinical evaluation of certain artificial intelligence software.

NMPA opens consultation of draft Opinions on Further Strengthening the Supervision of Entrusted Production by Medical Device Registrants

The China National Medical Products Association (NMPA) has released the draft Opinions on Further Strengthening the Supervision of Entrusted Production by Medical Device Registrants (link in Chinese) for public consultation until August 20, 2023. This draft document outlines opinions on fully implementing the main responsibility of registrants for the quality and safety of medical devices, preventing and controlling hidden risks in medical device-entrusted production and strengthening the supervision of medical device-entrusted production.

NMPA releases Opinions to Further Strengthen and Improve the Classification Management of Medical Devices

The NMPA has published a document (link in Chinese) that states its opinion on further strengthening and improving the classification management of medical devices. Notably, this document discusses relevant key tasks such as the optimization of the organizational systems for classification management, improvement of system, efficiency, capabilities, service level of classification management and strengthening supervision of classification implementation.