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599 results
  • new
Doctor viewing an MRI on a tablet while standing in front of the patient laying inside the MRI
  • Regulatory Update
Jul 31, 2025

Malaysia MDA Describes China NMPA IVD Regulatory Reliance Pilot

How does the new IVD regulatory reliance pilot between the MDA and NMPA work?
  • new
Business professional sitting on a couch while using a tablet
  • Regulatory Update
Jul 29, 2025

EU Postpones Master-UDI Assignment Deadline for Contact Lens Makers

Manufacturers must assign a “Master UDI-DI” to contact lenses by November 9, 2026.
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  • Regulatory Update
Jul 24, 2025

ANVISA Publishes More UDI Guidance

ANVISA published guidance on RDC 591/2021. Some requirements became mandatory July 10.
Malaysia Flag
  • Regulatory Update
Jul 23, 2025

Malaysia MDA Furthers Regulatory Reliance with China NMPA

Malaysia’s Medical Device Authority announced initiatives related to joint assessments with China’s NMPA.
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  • Regulatory Update
Jul 22, 2025

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).
Medical Device Market Access Consulting
  • Regulatory Update
Jul 21, 2025

COFEPRIS Updates Equivalency Agreement with Reliance Applicability Details

COFEPRIS published an update on expanded equivalency options, this time focusing on reliance applicability details.
graphic checklist
  • Regulatory Update
Jul 17, 2025

GPAI with Systemic Risks: Additional Safeguards

In this article, we focus on the additional safeguards that apply to GPAI models with systemic risks.
Elderly person measuring their blood pressure
  • Regulatory Update
Jul 15, 2025

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?
Blood pressure monitors and drug test kits on display
  • Regulatory Update
Jul 14, 2025

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...
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  • Regulatory Update
Jul 10, 2025

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...
Reading IFUs
  • Insights
Jul 7, 2025

5 Methods for Evaluating Your Instructions for Use: Benefits and Drawbacks

We provide five methods to evaluate instructions for use.
Two people in a dark office reviewing data on a computer
  • Regulatory Update
Jul 7, 2025

FDA Releases Final Guidance on Medical Device Cybersecurity

We explain the requirements of recent FDA cybersecurity guidance.
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