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The FDA's updated AI-enabled medical device list covers 1,614 products with decision dates from 1995 to 2026. Radiology …

Health Canada's updated FRM-0577 and FRM-0578 forms introduce online submission, new compliance declarations and product…

Vietnam's Decree 293/2026/NĐ-CP implements the Hague Apostille Convention from 11 September 2026, removing consular lega…

Russia's Ministry of Health has drafted an order to repeal Order No. 133н, the administrative procedure for EAEU medical…

ANMAT Notice 5461/2026 introduces a maximum ARS 5 million cap on medical device import fees based on FOB value. Learn wh…

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) has issued Resolution 236/2026, implementing Decree 892/25, which rela…

Argentina's ANMAT introduces a notification-based filing system for Class I/II medical devices and non-cold-chain IVDs, …

Australia's TGA confirms acceptance of extended EU MDR transition deadlines for MDD certificates. Learn about eligibilit…

WHO has published its first list of transitional authorities for medical devices, with China’s NMPA included. Learn what…

MDSAP AU P0002.011 introduces key changes to risk management, personnel competence, UDI, cybersecurity, design controls …

The Singapore Health Sciences Authority (HSA) has established requirements for the implementation of the Unique Device Identification (UDI) system for…

The European Union has officially introduced the Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR), replacing the Packaging and Packaging W…