The National Medical Products Administration (NMPA) has released the “Medical Device Emergency Use Management Measures” for public consultation. The draft proposals are open for feedback until February 15, 2023. These measures aim to streamline the emergency use of medical devices, particularly during public health emergencies.
Emergency Use Criteria
Emergency use will be applicable to medical devices that either have no similar products available in China or where existing products have insufficient manufacturing capacity or approved use range to meet urgent needs. This includes devices required for serious public health emergencies or other circumstances that significantly impact public health. Category 1 medical devices are excluded from these measures.
Implementation and Oversight
The National Health Commission (NHC) and the Chinese Center for Disease Control and Prevention (CDC) will develop an emergency use list and organize provincial-level supervision. The NMPA, in coordination with the NHC and CDC, will publish emergency use lists and corresponding plans, including details such as enterprise names, product names, emergency use range, and deadlines. If an imported device is involved, the General Administration of Customs will be notified by the NMPA to facilitate the emergency use of these products.-Fineline Info & Tech
