AI Tools

Our weekly regulatory news round-up includes the US FDA's debut of “Elsa,” an agency-wide generative-AI platform to speed reviews and boost efficiency. In addition, Mexico’s COFEPRIS announced sweeping Plan Mexico reforms aimed at digitizing procedures, reclassifying 2,200 devices, and slashing clinical-protocol review times in a bid to become a WHO-listed authority.

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.