PURE Global CEO on AI & Data Analytics Revolutionizing Markets

This week in global device regulatory news, Malaysia’s MDA issued updated ASEAN guidance on borderline products and risk-based classifications, Mexico’s COFEPRIS proposed faster equivalency pathways that accept IMDRF- and MDSAP-member approvals, and Brazil’s Anvisa cancelled IVD devices that missed the RDC 830 reclassification cutoff.

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.