Consultation: TGA Annual Charge Exemption (ACE) Scheme Compliance Program Updates proposal 2026-27 We have opened a consultation to provide industry and other interested stakeholders with an opportunity to comment on the our proposed updates to the ACE Scheme Compliance Program View article...
Ben KempFebruary 26, 2026
TGA have updated their UDI requirements guidance - https://www.tga.gov.au/resources/guidance/complying-unique-device-identification-requirements-medical-devices
Ben KempFebruary 26, 2026
UKRI strategy builds on UK's strength and potential in AI In its first AI strategy, UKRI sets out a bold plan to build on the UK’s incredible strengths and potential in areas including explainable AI, edge computing, human-in-the-loop systems, agentic AI and sustainable AI systems. The strategy will turn AI research into practical benefits for people – from real-world…
Ben KempFebruary 26, 2026
Dear Members, if you make shipments to the EU, please see the revised EU threshold-based customs duty relief below. CELEX:32026R0382: Council Regulation (EU) 2026/382 of 11 February 2026 amending Regulation (EC) No 1186/2009 as regards the elimination of the threshold-based customs duty relief for shipments with intrinsic value not exceeding €150.00 View article...
Ben KempFebruary 20, 2026
Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU Health Technology Assessment Regulation. The report presents the key achievements of the HTACG and its four subgroups in 2025, covering joint…
Ben KempFebruary 20, 2026
Take a deep dive into EU cardiovascular health data An online tool which helps policymakers, researchers, and the public monitor cardiovascular health across the EU was launched today. The new State of Cardiovascular Health in the European Union Dashboard was unveiled at a webinar hosted by the European Commission and the OECD which explored the report State of Cardiovascular Health…
Ben KempFebruary 19, 2026
TGA Australia, have opened their consultation on fees for 2026/2027: View article...
Ben KempFebruary 19, 2026