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…
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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.
Updated Guidance on the FDA Q-Submission (Q-Sub) Program
Discover the latest FDA Q-Submission Guidance to improve medical device submissions, gain early feedback, and streamline your FDA regulatory strategy.
COFEPRIS Warehousing Compliance for Medical Devices
Learn about COFEPRIS warehouse requirements in Mexico for medical devices and IVDs, covering licensing, storage, and distribution compliance.
Tips for Manufacturers Preparing for an FDA PMA Submission
Discover practical tips and key strategies to improve your FDA PMA submission.
IVDR Transition Deadline What Happens After May 26, 2025
Prepare for the IVDR Transition Deadline on May 26, 2025. Learn what legacy IVD manufacturers must do to maintain EU market access.
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