Reg with MEG Podcast Por MedEnvoy Global arte de portada

Reg with MEG

Reg with MEG

De: MedEnvoy Global
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Reg with MEG brings together industry experts to explore the ever-changing world of global medical device compliance. From EU MDR/IVDR and FDA pathways to regulatory importer obligations, Post Market Surveillance (PMS), and market access, we break down complex regulatory topics into clear, actionable conversations.MedEnvoy Global Economía
Episodios
  • Australia TGA Post-Market & Vigilance Rules

    Australia TGA Post-Market & Vigilance Rules
    Mar 10 2026

    In this episode, we break down key compliance obligations, including annual reporting for high-risk devices, adverse event reporting timelines, and Australia’s PRAC process for recalls and market actions. Learn what sponsors and manufacturers must do to stay compliant in the Australian market.

    #tgaaustralia #postmarketsurveillance #artg #vigilancereporting #medicaldevice


    Note: This episode was created and hosted with AI.
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    12 m
  • Regulatory News Recap | Health Canada 2026 Updates Explained

    Regulatory News Recap | Health Canada 2026 Updates Explained
    Mar 3 2026

    Big 2026 changes from Health Canada are now live. Class II–IV devices must use REP and submit through the Common Electronic Submissions Gateway; email is no longer accepted. We also cover stricter screening, new post-market Terms & Conditions, and IMDRF alignment.
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    9 m
  • FDA 2026 General Wellness Update: What Changed?

    FDA 2026 General Wellness Update: What Changed?
    Feb 23 2026

    The FDA updated its General Wellness guidance. Here’s what changed for digital health apps, wearables, and low-risk devices and what it means for you.
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    10 m
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