Preview of Supplementary Files Available to First-Time Medical Device Registrants

On 12.09.2018, the CMDE (Center for Medical Device Evaluation) announced that they will provide a pre-reviewing service for supplementary documents of medical device starting 08.10.2018 (CMDE No. 08-2018). This service will be available for domestic Class III, as well as imported Class II and III medical devices if it is the first NMPA (China Food and Drug Administration) registration in China. With this service, CMDE aims to ensure that the prepared supplementary files fulfil the requirements as they can only be submitted once after the receipt of the corrective notice.