SDA formally joined imdrf national regulatory agency report information exchange mechanism

On September 19, at the 16th Management Committee meeting of the international medical device regulatory Forum (imdrf) held in Yekaterinburg, Russia, the Chinese delegation applied to the management committee to join the imdrf national regulatory agency reporting information exchange mechanism, which was unanimously approved by Member States Imdrf national competent authorities report (NCAR) information exchange mechanism is established to establish a channel for drug regulatory agencies to share medical device safety information, so that member countries can exchange relevant information such as adverse events of medical devices that may cause serious public health and safety events or have potential risk trends in a timely manner At present, more than 20 countries and regions have joined the cooperation mechanism By joining NCAR information exchange mechanism, SDA will help China to obtain safety information such as adverse events of international medical devices in time, study and control risks of related imported products in time, and effectively protect and promote public health At the same time, it also helps our country to participate in the construction of the global safety supervision network of medical devices, and make our due contribution to the global medical device supervision and the development of global health undertakings Next, SDA will organize and carry out information exchange and sharing with relevant member countries according to the work requirements, timely understand the information and regulatory measures of major adverse events of global medical devices, and provide strong information support to ensure the safety and effectiveness of medical devices in China This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.