UK MHRA Updates Medical Device Registration Guidance wi…
On 20 February 2026, the Medicines & Healthcare products Regulatory Agency published an update to its guidance on registering medical de…
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EMA Issues Final Elemental Impurity Risk Management Gui…
On February 20, 2026, the European Medicines Agency published final guidance setting out risk management requirements for elemental impuriti…
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Australia TGA Updates Guidance on AI-Enabled Medical De…
On February 5, 2026, the Therapeutic Goods Administration (TGA) published updated guidance clarifying how artificial intelligence enabled so…
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EU Commission Releases EUDAMED Version 2.22.0 With Mand…
On 5 January 2026, the European Commission announced the production release of EUDAMED version 2.22.0, introducing mandatory system updates …
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Saudi SFDA Outlines Artificial Intelligence Adoption in…
On 28 January 2026, the Saudi Food and Drug Authority announced an advisory highlighting its integration of artificial intelligence AI into …
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Finland’s FIMEA Issues Guidance on EU AI Act Requirem…
On January 19, 2026, Finnish Medicines Agency (FIMEA) published guidance on the use of artificial intelligence in medical devices, marking t…
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FDA Launches ImportShield Program to Strengthen Oversig…
On January 21, 2026, the U.S. Food and Drug Administration (FDA) announced the launch and initial results of the FDA ImportShield Program (F…
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Indonesia Ministry of Trade Introduces Import Ban on Su…
On January 2, 2026, Indonesia’s Database of Legislation published a new Ministry of Trade regulation that introduces a ban on the importat…
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UK MHRA Updates Guidance on Determining Borderline Prod…
On 17 October 2025, the Medicines & Healthcare products Regulatory Agency (MHRA) published updated guidance on borderline products, clar…
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US FDA Announces Deployment of Agentic AI Capabilities …
On December 1, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of new agentic AI capabilities to enhance pre-mark…
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