ANVISA Publishes More UDI Guidance
ANVISA published guidance on RDC 591/2021. Some requirements became mandatory July 10.
Malaysia MDA Furthers Regulatory Reliance with China NMPA
Malaysia’s Medical Device Authority announced initiatives related to joint assessments with China’s NMPA.
MHRA releases consultation outcome on future medical device legislation
We discuss the UK MHRA’s proposed amendments to the Medical Devices Regulations 2002 (MDR 2002).
COFEPRIS Updates Equivalency Agreement with Reliance Applicability Details
COFEPRIS published an update on expanded equivalency options, this time focusing on reliance applicability details.
GPAI with Systemic Risks: Additional Safeguards
In this article, we focus on the additional safeguards that apply to GPAI models with systemic risks.
Mexico’s COFEPRIS Updates Low-risk and Deregulated Medical Devices List
Mexican regulators have updated the list of low-risk medical devices. Have requirements for your products changed?
A Shift in the Compliance Landscape: The EU GPAI Code of Practice is Here
New AI-driven healthcare devices placed on the European market must comply with the General-Purpose AI Code of Practice by August 2026 and existing models by August 2027. Will your medical devices comply?
UK MHRA Publishes Common Specification Requirements for IVD Devices
Keep up with IVD regulations in the UK. See our analysis of the outcome of the UK medical device regulator’s consultation and its impact on IVD manufacturers.
FDA Releases Final Guidance on Medical Device Cybersecurity
We explain the requirements of recent FDA cybersecurity guidance.
Is it Too Bold to Refer to this as the Quarter of Data Accessibility?: Second Quarter 2025 Developments
Follow our coverage of medical device regulatory news with this examination of developments from the second quarter of 2025.