Netherlands MEB Introduces Declaration Requirement for …
On March 11, 2026, the Medicines Evaluation Board (MEB) in the Netherlands published new declaration guidance for applicants seeking Duplex …
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MHRA and NICE Launch Aligned Licensing and HTA Process …
On March 17, 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence …
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Saudi Arabia SFDA Updates Product Classification Guidan…
The Saudi Food and Drug Authority (SFDA) published updated product classification guidance on January 20, 2026, clarifying regulatory r…
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FDA Issues Draft Guidance on Three-Year Clinical Invest…
On March 4, 2026, the U.S. Food and Drug Administration (FDA) published a draft guidance document addressing three-year clinical inves…
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EU CENELEC Publishes EN IEC 60601-2-57:2026 Safety Stan…
On 27 February 2026, CENELEC published a new European safety standard covering non-laser light source equipment used in medical and aestheti…
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NPRA Malaysia Mandates Declaration of Competent Personn…
On 23 February 2026, the National Pharmaceutical Regulatory Agency (NPRA) published a new directive under the Drugs and Cosmetics Control Re…
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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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