Industry Trend Analysis - UDI Will Further Harmonise Chinese Medical Device Regulations

摘要

China will continue to take steps to harmonise its medical device regulations and improve medical device surveillance. China's participation in the IMDRF's adverse event exchange programme will increase safety. New UDI requirements, announced for the first batch of Class III medical devices, will strengthen market surveillance.China will continue to take steps to harmonise its medical device regulations and improve medical device surveillance in line with International Medical Device Regulators Forum (IMDRF) standards. In September 2019, the National Medical Products Administration (NMPA) officially joined the IMDRF's adverse event exchange programme. Participation by the NMPA gives it access to information on international adverse events and inspection evaluations to assist the agency in assessing the risks of imported products. It will also allow China to participate in the development of a global medical device safety monitoring network. To date, more than 20 countries and regions have joined the programme.