FDA UDI Requirements for Combination Products
The U.S. FDA has released a draft guidance on FDA UDI Requirements clarifying how UDI requirements…
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Medical Device Regulatory Frameworks: New Zealand vs. Australia
To better understand how the medical device frameworks of Australia and New Zealand function in practice, it is essential to…
FDA Cybersecurity Guidance for Medical Devices
The U.S. Food and Drug Administration (FDA) has issued updated guidance titled “Cybersecurity in Medical Devices:…
COFEPRIS Enhances International Product Recognition
The Mexican authority, COFEPRIS, has expanded its international recognition by now accepting regulatory decisions from trusted global authorities (e.g., FDA,…
MHRA Sets a New Strategic Vision: Speed, Safety, and Innovation
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) unveiled its refreshed strategic directions and overall vision at the DIA…
MDCG 2025-5: New IVDR Guidance on IVD Performance Studies
The Medical Device Coordination Group (MDCG) has published MDCG 2025-5 “Questions & Answers regarding performance studies…
New UK PMS Update to the Medical Devices Regulations 2024
The passing of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which amends…
TGA PMS and Vigilance Requirements for Medical Devices
TGA PMS and Vigilance Requirements for Medical Devices.
New FDA Guidance on 510(k) Transfer for Medical Devices
A New FDA 510(k) transfer draft outlines key steps for medical device companies.
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