On September 19, at the 16th management committee meeting of IMDRF held in Yekaterinburg, Russia. The application to join National Competent Authorities Report information exchange mechanism of IMDRF submitted by the Chinese delegation was unanimously approved by the member states.
The purpose of IMDRF National Competent Authorities Report (National Competent Authorities Report, NCAR) information exchange mechanism is to establish a channel for the sharing of medical device safety information among national drug regulatory authorities, so that member states can timely exchange relevant information such as medical device safety events that may cause serious public health safety incidents or adverse events with potential risk trends. More than 20 countries and regions have joined the cooperation mechanism.
NMPA joined the NCAR information exchange mechanism, it is helpful for China to timely learn safety information such as adverse events of international medical devices, timely study and control risks of relevant imported products, and effectively protect and promote public health. At the same time, it is also helpful for China to participate in the co-construction of the global safety supervision network of medical devices, and make its due contribution to the development of global medical device supervision and global health.