EU Expands eIFU for Medical Devices
On 25 June 2025, the European Commission published Implementing Regulation (EU) 2025/1234, which amends Implementing…
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FDA UDI Requirements for Combination Products
The U.S. FDA has released a draft guidance on FDA UDI Requirements clarifying how UDI…
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…
FDA Cybersecurity Guidance for Medical Devices
The U.S. Food and Drug Administration (FDA) has issued updated guidance titled “Cybersecurity in Medical…
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.,…
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…
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…
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…
TGA PMS and Vigilance Requirements for Medical Devices
TGA PMS and Vigilance Requirements for Medical Devices.
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