China's National Medical Products Administration has issued Announcement No. 58 revising the classification framework for AI-enabled medical devices, introducing a dedicated sub-category for AI decision-support software and clarifying the boundary between Class II and Class III risk assignment for AI diagnostic tools.
Read more →Swissmedic has published an update to the Switzerland–UK Mutual Recognition Agreement annex, extending bilateral certificate recognition to Class IIa active devices and Class IIb non-implantable devices, subject to a post-market surveillance equivalence review completed within 12 months of first placement on the Swiss market.
Read more →Israel's Ministry of Health has issued a directive requiring that all new clinical performance studies supporting Class C in vitro diagnostic device registrations comply with ISO 15189:2022 laboratory quality requirements. Existing studies conducted under the 2012 edition will be accepted through 31 March 2027.
Read more →Turkey's Pharmaceuticals and Medical Devices Agency has amended the Medical Device Labeling Regulation, requiring all labeling to include a Turkish-language IFU effective 01 October 2026 and mandating that electronic IFU systems provide a QR code directly on the primary device label rather than only on outer packaging.
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