China’s NMPA just released 38 medical device industry standards: what they are, who’s affected, and how to prepare
China , October 23, 2025 — China’s National Medical Products Administration (NMPA) has officially released 38 new and revised YY/YY-T industry standards for medical devices and in vitro diagnostics (IVDs). These standards establish the baseline for type testing and dossier preparation in device registrations. Most will take effect on July 1, 2026, with a few […]
MHRA’s New Annual Device Registration Fee: What the October 2025 Update Means for Manufacturers and UKRPs
United Kingdom, October 2025 — The Medicines & Healthcare products Regulatory Agency (MHRA) has overhauled the fee system under Regulation 53 of the UK Medical Devices Regulations 2002 (SI 618, as amended). The revision follows a joint MHRA / Northern Ireland Department of Health consultation (Aug–Oct 2024) on sustainable cost recovery. It aligns with the […]
EU Updates Harmonised Standards for Medical Devices — What It Means for Manufacturers
European Union, 20 October 2025 — The European Commission has released Implementing Decision (EU) 2025/2078, updating the list of harmonised standards under the EU Medical Device Regulation (MDR 2017/745). This decision introduces newly revised standards that medical device manufacturers must adopt to maintain the presumption of conformity for their products within the MDR framework. Get […]