This week in global device regulatory news, Singapore’s HSA kicked off a pilot Change Management Program for SaMD, began Phase 2 UDI labelling for Class D devices, and issued joint clinical-trial principles for machine-learning devices with Korea; Brazil’s Anvisa published a draft user manual for its forthcoming UDI database; and Turkey’s TITCK mandated six-month supply-interruption notices while tightening ÜTS registration for IVDs re-classified under the IVDR.

This week in global device regulatory news, Team-NB issued a position paper on how the EU AI Act meshes with MDR/IVDR, the UK MHRA refreshed its MORE guidance ahead of new post-market-surveillance rules, Swissmedic adopted the EU’s MIR Form v7.3.1 for serious-incident reporting, Brazil’s Anvisa opened a consultation on single-use device processing practices, and China’s NMPA updated its catalogue of devices exempt from clinical evaluation.

This week in global device regulatory news, the US FDA unveiled plans for unannounced inspections at foreign device manufacturing sites, and Brazil’s Anvisa opened a targeted consultation on a new device framework while setting phased dates to integrate health‑surveillance fee payments into its foreign‑trade portal.

This week in global device regulatory news, the European Commission rolled out MIR Form v7.3.1 for MDR/IVDR incident reporting, Switzerland advanced streamlined review for FDA-cleared devices, Peru created the autonomous Apemed authority to replace Digemid, and China issued new quality standards for online medical‑device sales and released registration‑review guidelines for ten products.

This week in medical device regulatory news, the FDA launched ESG NextGen, a modernized platform for secure electronic submissions that replaces the legacy WebTrader system; and Brazil’s Anvisa reclassified ultrasensitive CRP devices from Risk Class III to Class II, simplifying the regulatory pathway from registration to notification.

This week in global device regulatory news, SFDA has introduced major changes to GHTF MDMA license renewal and update requirements and the European Union has updated harmonised standards for medical gloves, device sterilization, and ambulance equipment.

New Australian UDI regulations are now in effect, the impact of the revised EU REP symbol on medical device labeling in the European Union, Mexico's COFEPRIS has announced modifications to GMP requirements, and more in this week's global medical device regulatory updates.

Mexico's COFEPRIS introduced new guidelines for compliance with GMP requirements, the EU reclassified SARS-CoV-2 testing devices, China NMPA issued new guidelines and requirements for medical device inspections, and more in this week's global medical device regulatory update.

This week in medical device regulatory news, the European Commission has updated official guidance on the classification of IVDs under the IVDR; Brazil has opened public consultation on UDI database management and suspended electronic signature requirements; and China revised its regulations on domestic production of imported medical devices.