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What is the role of the Therapeutic Goods Administration (TGA)? What types of medical technologies does it regulate? And when should you start thinking about regulation?

This video provides an accessible introduction to TGA medtech regulation in Australia.

The session will provide an overview of the TGA, the Australian regulatory framework and how regulation applies to medical technologies in practice.

What you’ll take away

You’ll gain a foundational understanding of:

  • The role of the TGA and where it fits within Australia’s healthcare system
  • The regulatory framework for therapeutic goods in Australia
  • How regulation applies to medical devices, IVDs and combination products
  • Key regulatory considerations for people developing or researching medical technologies
  • When to engage with the TGA
  • Examples that bring the regulatory framework to life

Speakers

Dr Monika Srivastava
Assistant Director, Regulatory Science and Capability Unit
Scientific Evaluation Branch, Therapeutic Goods Administration

Dr Jackson Williams
Assistant Director, Medical Device Authorisation Branch
Therapeutic Goods Administration