The National Medical Products Administration (NMPA), National Health Commission (NHC), and Chinese Center for Disease Control and Prevention (CDC) have jointly issued the “Medical Device Emergency Use Management Rules (trial),” which are effective immediately. These rules govern the emergency use of medical devices within a specified scope and period for the prevention and control of particularly serious public health emergencies or other significant threats to public health. The emergency use is warranted in situations where no similar products are registered in China, or when existing similar products cannot meet emergency demand, excluding Class I medical devices.
The NMPA is tasked with organizing expert discussions to determine the list of urgently usable medical devices and their manufacturers. Upon receiving the notice, manufacturers must submit relevant qualification documents, product information, supply capacity details, and company operation status. Provincial drug regulatory departments will guide manufacturers, organize production, and supervise the management of devices and products approved for emergency use. For imported medical devices, the NMPA will report to the General Administration of Customs.
Manufacturers are required to monitor adverse events, conduct risk analysis and evaluation, and report in writing for emergency-use medical devices. Products must be prominently labeled “for emergency use only” and with an expiration date. The rules emphasize the establishment of a comprehensive traceability management system. Non-compliant products or those with defects must be immediately discontinued and recalled. The emergency use will automatically terminate when the public health emergency ends or the emergency use period is reached. If significant safety issues or quality defects arise, or if registered products can meet usage needs, the NMPA, in conjunction with the NHC and the CDC, will terminate the emergency use.- Flcube.com
