Director, Seconded European Standardization Expert in China (SESEC) at CEN, CENELEC, ETSI, EC and EFTA funded project
On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices, stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. The Rules encompass three parts: https://lnkd.in/gggZqxNs