NMPA officially joins IMDRF NCAR Exchange Program
The International Medical Device Regulators Forum (IMDRF) held its 16th management committee meeting on Sept 19 in Yekaterinburg, Russia, during which member countries unanimously approved the Chinese delegation's application to join the IMDRF National Competent Authorities Report (NCAR) Exchange Program.
The IMDRF NCAR Exchange Program was established to set up channels for sharing information on medical device safety among drug regulatory agencies of different countries, enabling member countries to exchange information in a timely manner on medical device adverse events that could trigger serious public health issues or indicate potential risk trends.
At present, over 20 countries and regions have joined the cooperation mechanism.
Participation of the National Medical Products Administration (NMPA) in the mechanism provides China with access to safety information on international medical device adverse events and facilitates evaluation and control of the risks associated with imported products, so that NMPA is better positioned to protect and promote public health.
Meanwhile, by joining the NCAR Exchange Program, the NMPA will be able to contribute more to global medical device regulation and the development of global health by participating in the construction of the global network of medical device safety surveillance.
Next, the NMPA will press ahead with information exchanges and sharing with other member countries in accordance with the working requirements and pay close attention to major global medical device adverse events information and regulatory measures, so as to provide strong data support for ensuring the safety and effectiveness of medical devices in China.