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  • new
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  • Regulatory Update
May 5, 2025

European Commission Releases New Management Incident Report Form and Help Text

Read our regulatory experts’ timely summary of this latest medical device regulatory development from the European...
  • new
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  • Regulatory Update
May 5, 2025

Switzerland Continues Efforts to Recognize Non-European Regulatory Authorizations

The Swiss Federal Assembly voted to approve Motion 20.3211, which mandated the Swiss Federal Council to adopt...
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  • Regulatory Update
May 1, 2025

QMS Developments in South Africa: SAHPRA joins MDSAP and starts to require ISO 13485

The South African Health Products Regulatory Authority (SAHPRA), announced two important Quality Management System...
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  • Regulatory Update
Apr 15, 2025

South Korea’s MFDS Revises K-GMP Regulations for Medical Devices and IVDs

South Korea’s Ministry of Food and Drug Safety (MFDS) has revised legislation related to manufacturing and quality...
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  • Regulatory Update
Apr 14, 2025

Mexico’s COFEPRIS publishes the final version of the GMP Standard

We discuss final updates to NOM-241-SSA1-2025 on Good Manufacturing Practice (GMP), their relevance, and how they...
Korean building at night
  • Regulatory Update
Apr 14, 2025

South Korea’s Digital Medical Products Act Now Enforced

South Korea’s Ministry of Food and Drug Safety (MFDS) announced that the Digital Medical Products Act entered into...
Sydney Australia
  • Regulatory Update
Apr 10, 2025

Australian Unique Device Identification (UDI) Framework Now in Effect

Australia’s medical device regulator, the Therapeutic Goods Administration, has announced that its Unique Device...
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  • Regulatory Update
Apr 7, 2025

FDA ESG NextGen Now Open for Test Submissions

The test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) has been opened by the...
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  • Regulatory Update
Apr 3, 2025

District Court Ruling on FDA Final Rule Regarding Laboratory Developed Tests (LDTs)

Medical device manufacturers operating in the United States (U.S.) need to be aware of new rules for obtaining market...
AI and MI enabled medical devices
  • Regulatory Update
Apr 1, 2025

Risk Categorization Per the European AI Act

Our Emergo by UL experts explain the importance of risk categorization in complying with the European Artificial...
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  • Regulatory Update
Mar 14, 2025

Health Canada Continues to Actively Monitor Supply of Medical Devices

The Canadian medical device regulator Health Canada continues to add and remove devices deemed in short supply.
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  • Regulatory Update
Mar 12, 2025

IMDRF Updates Terminologies for Categorized Adverse Event Reporting

The technical document that defines the categories for adverse event reporting for medical devices has been updated by...
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