What's Changed? In July 2026, France's National Agency for the Safety of Medicines and Health Products (ANSM) reinforced its expectations regarding medical device vigilance and post-market surveillance, publishing updated guidance to help manufacturers, importers, and economic operators comply with the European Union Medical Device Regulation (EU MDR). The updated guidance highlights manufacturers' responsibilities for reporting serious incidents, monitoring device performanc

As published by the DMEC of MoH Vietnam on 5 August 2024, Decision No. 2302/QD-BYT will replace Decision No.3007/QD-BYT regarding...

Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...