Why the IVDR preapplication process matters for legacy manufacturers

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.