TGA Publishes List of AI-Enabled Medical Devices
On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical devices…
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TGA Focuses on AI and Software-Based Medical Devices
The Therapeutic Goods Administration (TGA) has published a new regulatory focus on artificial intelligence (AI) and other software-based medical devices.
New MHRA Guidance on Clinical Investigations Notifications
On 27 August 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated set of flow charts…
FDA Guidance on PCCP AI-Enabled Medical Devices
On August 18, 2025, the FDA issued final guidance for industry on how to include a…
New Medical Device Approval: Regulatory COFEPRIS Reforms
On August 22, 2025, as part of the new COFEPRIS regulatory reforms, the authority issued a new agreement concerning medical…
MDCG Issues Master UDI-DI EU Guidance for Contact Lenses
Today, the EU published an updated revision of the Medical Device Coordination Group (MDCG) Guidance document…
Swissmedic Rolls Out New Swissdamed UDI Devices Module
Swissmedic has unveiled a significant enhancement to the Swiss database for medical devices, Swissdamed, with the launch of its UDI…
Digital Scribes: TGA Guidance Overview
The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also known…
New AI Insights in EU Healthcare: Opportunities & Challenges
Healthcare systems are facing a rising demand due to aging populations, an increase in chronic and complex conditions, growing costs,…
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