Therapeutic Goods Administration (TGA)

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

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

Since September 2021, ANDHealth and the TGA have supported 192 companies to increase their understanding of regulatory requirements, including the type of evidence required when seeking regulatory approval by the TGA, when regulatory approval is not required, how to list a device on the Australian Register of Therapeutic Goods (ARTG) and the differences between Australia and other international markets.

The extended partnership will see TGA fund ANDHealth to deliver industry-wide training to over 350 participants from the Australian digital health sector in the next 12 months. The program includes 10 virtual workshops and over 150 hours of direct one-to-one coaching for digital health SMEs seeking to navigate Australia’s Software as a Medical Device (SaMD) regulatory environment, supporting them to accelerate the commercialisation of their products.

“Our partnership with the TGA puts Australia’s emerging digital health innovators in the best position to effectively navigate the regulatory environment and pursue clinical programs that make their ground-breaking health technologies globally marketable.”

– Bronwyn Le Grice, CEO and Managing Director, ANDHealth

Click here for more information.

Opportunities for support and engagement  
Digital Health Webinars
With speakers from the TGA and live Q&A.

Upcoming dates
Webinar 1: An Overview: SaMD Regulation by the TGA | 11am AEST Wed 3 Aug 2022

Webinar 2: SaMD Regulation for Clinical Decision Support Software Companies |
11am AEST Wed 7 Sep 2022
Support Navigating SaMD
One-on-one Office Hours session with ANDHealth, to support companies navigate SaMD. These sessions provide an opportunity to discuss general queries on the SaMD regulations, or navigating regulations for a specific software-based or digital health product or solution.

“ANDHealth is an invaluable resource for SMEs in the health tech startup space that need assistance to navigate the health ecosystem so that we can maximise our innovation time and investments.”

- TGA SaMD Webinar Attendee

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