Medical Devices

China’s IVD reagent classification catalogue has been revised and reissued for industry comment. The deadline for submission is Apr. 12, 2023

GB9706 standards for medical electrical equipment have new NMPA guidelines to help applicants determine the implementation dates

China’s Medical Device Supplementary Notice Period reverts to 1-year period from previous 2-year temporary extension, commencing Feb 20, 2023

New registration review guidelines have been issued by China’s CMDE for dental adhesive products for dental filling and restoration, as well as restoration and bonding.

China medical device standards management 2022 annual report was issued on February 8, 2023, to provide an overview of standards development

Medical device registrations China 2022 Annual Report shares an overview of the 11,942 medical devices successfully registered over the year

China UDI medical device third batch implementation date is June 1, 2024, as part of the continuing drive to improve supervision and...

Medical Device Master Files in China were introduced in 2021 but the NMPA has clarified their use for the registration of medical devices

China medical device standards February 2023 updates cover 33 mandatory and recommended standards for specific medical electrical equipment

China medical device sampling inspection results no. 4 of 2022: Ten varieties of medical devices were sampled and inspected for quality...

China medical device quality safety responsibility regulations were issued by NMPA and will come into force on March 1, 2023.

China post-market surveillance regulations for medical devices in 2022 were being reviewed in a meeting carried out by the NMPA.