Therapeutic Goods Administration (TGA)

Supporting Navigation of the Regulatory Landscape for Software-based Digital Health Products

The joint TGA-ANDHealth initiative will support Australian SMEs to navigate the regulatory guidance and compliance requirements for Software as a Medical Device (SaMD).

It will also provide a conduit for the digital health industry to communicate directly with the TGA, providing feedback that will strengthen future regulatory development and guidance documentation.

Click here for more information.
Opportunities for support and engagement  
Digital Health Webinars
Speakers from the TGA and live Q&A.
next webinar is, 11 am – 12 am AEDT. 1 Feb 2022.
Book NOW for Feb Webinar.
Support Navigating SaMD
One-on-one Office Hours session with ANDHealth, to support companies navigate SaMD. Bookings open now!
Book here.
Feedback Portal
To gather your feedback, queries and suggestions to drive improvement and clarity to the TGA guidance provided.

This is your opportunity to give feedback
on Software as a Medical Device regulations to the TGA in the form of:
-General feedback and suggestions, or
-Feedback on a TGA regulation/guidance document.

Submit your feedback here.
“Having a strong regulatory environment for digital heath products not only provides access to safe, evidence-based digital health products to improve patient outcomes, but also improves the commercial potential of new innovations.”

- Bronwyn Le Grice, CEO and Managing Director, ANDHealth

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