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Ben Kemp

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Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing): SOR/2024-238

Amendments have been made to the Food and Drug Regulations and Medical Devices Regulations that advance Health Canada’s modernization agenda by making Canada’s science-based regulatory system more agile and internationally aligned. Find out more here.
Ben Kemp
January 16, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

UPDATED – MDCG 2023-3 Q&A on vigilance terms and concepts

MDCG have update Guidance MDCG 2023-3 Q&A on vigilance terms and concepts to Revision 2. There have been several editorial changes made to footnote 8 (adapted to gradual roll-out of Eudamed), Q21 (changed reference to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’) and Footnote 34 (timeline for FSN clarified). You can find the updated document via the link: https://health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf…
Ben Kemp
January 16, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance – updates

Please find below the recently published Guidance and draft guidance documents: Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | FDA Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers | FDA Global Unique Device Identification Database…
Ben Kemp
January 16, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus standards updated

Please find the updated FDA Consensus standards: Recognized Consensus Standards: Medical Devices See this list edited to remove obvious non IVD related standards, and new entries highlighted in yellow. Remember that you can check the specifics of the degree of recognition by using the links on the righthand side of the FDA web page.
Ben Kemp
January 16, 2025
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