International Medical Device Regulatory Governance

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01

Course description

A strategic course on global regulatory governance for medical devices, covering the role of international organisations (IMDRF, GHTF/SG3), regulatory convergence, regulatory reliance, reference agencies and the development of integrated strategies for access to multiple markets.

02

Course objective

Prepare leaders and senior professionals to plan global regulatory strategies, using convergence, reliance and mutual recognition mechanisms to optimise time to market across multiple jurisdictions.

03

Course programme

24h of in-depth learning
  1. 01

    The global medical device regulatory landscape

  2. 02

    IMDRF and the GHTF legacy (SG1 to SG5)

  3. 03

    Regulatory convergence and key documents (SG3/N19)

  4. 04

    Regulatory reliance and reference agencies

  5. 05

    Multi-jurisdictional strategies (ANVISA, FDA, MDR, Health Canada, TGA, PMDA, COFEPRIS, INVIMA, ANMAT)

  6. 06

    Integrated regulatory planning and market prioritisation

  7. 07

    Trends: QMSR, MDR, IVDR and harmonisation

04

Who can attend?

  • Regulatory Affairs managers and directors, strategic leaders, senior consultants, international market access professionals and decision-makers at medical device companies.