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…
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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…
FDA Guidance on PCCP AI-Enabled Medical Devices
On August 18, 2025, the FDA issued final guidance for industry on how to include…
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…
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…
EUDAMED: A Guide for Medical Device and IVD Manufacturers
The Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Regulation 2017/746 (IVDR) introduced the requirement for a new…
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…
MedEnvoy at RAPS Convergence 2025
We are excited to share that MedEnvoy will be participating in RAPS Convergence 2025 as an exhibitor! This year’s…
Digital Scribes: TGA Guidance Overview
The Therapeutic Goods Administration (TGA) has published guidance on the regulation of digital scribes, also…
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