Updated TGA Essential Principles Checklist
The Therapeutic Goods Administration (TGA) has released an updated version of the Essential Principles (EP) checklist for medical devices and…
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EU Launches Evidence on Targeted Revision of MDR and IVDR
The European Commission has launched a Call for Evidence on the planned targeted revision of the Medical Device Regulation (MDR,…
TGA Publishes List of AI-Enabled Medical Devices
On 4 September 2025, the Therapeutic Goods Administration (TGA) released a public list of medical devices…
Importing Medical Devices to India: Compliance Mistakes to Avoid
Medical device manufacturers with registrations in India often encounter compliance roadblocks during the importation process, even after a successful regulatory…
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…
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