On July 9, 2024, the National Medical Products Administration (NMPA) unveiled the statistics of medical device standardization activities in China. Specifically, the statistics cover three main aspects: the development of standards, the establishment of standard development organizations (SDOs), and China’s engagement in international standardization activities.
Standards development
By the end of June 2024, the number of medical device standards had reached 1,978, including 272 national standards and 1,706 sector standards. Among the national standards, 269 (approximately 13%) are mandatory, while the remaining are recommended standards. These standards basically cover all professional and technical fields of medical devices.
Establishment of SDOs
Standardization organizations for medical robots, AI-enabled medical devices, medical equipment industry and application, as well as traditional Chinese medical devices have been established. Currently, there are 39 SDOs for medical devices in total.
Engagement with the international community
The convergence of medical device standards in China with international standards has reached 95%. Such a high level of convergence is arguably related to the dominant role that foreign medical device manufacturers have in the industry. Since 2023, two international standards led by China have been released, while the preparation and revision of five international standards are in process. An example of an international standard project officially initiated in IEC is Artificial Intelligence–enabled Medical Devices — Computer assisted analysis software for pulmonary images – Algorithm performance test methods. In addition, two Chinese experts have been elected to hold the Chairmanship of IEC SC 62B and Vice Chairman of IEC TC62.
The statistics are dynamically tracked and documented by the NMPA. The body is also in charge of updating the medical device catalogue and compiling the annual report on the progress of standardization. For the catalogue in Chinese, please click here. For the latest annual report in English, please click here.
