WeAreTechWomen | Inspirational Woman: Phyllis Meng

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.