SaMD Regulation by the TGA: Digital Mental Health Tools

Join ANDHealth and the TGA on Tuesday 10 November for a focused webinar on Australian regulatory frameworks for digital mental health tools.

Explore how the TGA approaches the regulation of digital mental health products, including SaMD and mixed-function software. The session will unpack key definitions and help you understand which tools are classified as medical devices and which may be excluded or exempt.

Through expert insights and real-world case studies, our presenters will illustrate how regulations apply in this context. Following the presentation, attendees will be invited to participate in a live Q&A session directly with the TGA.

This session is designed to step through the regulatory journey and demonstrate how TGA guidance can be applied to a specific product. This joint TGA-ANDHealth initiative supports Australian SMEs to navigate the regulatory guidelines and compliance requirements for Software as a Medical Device (SaMD).

This is an important session for all Australian digital health SMEs who think they may be required to design and deliver robust clinical trials and evidence to support the safety and efficacy of their digital health products, as verified by the TGA.

Come along to have your regulatory questions answered!

WEBINAR DETAILS

Date: Tuesday 10 November 2026

Time: 11:00am - 12:00pm AEDT

Where: Online via Zoom Webinar

Registration*: Free to attend, but registration essential

Session format: TGA presentation followed by live audience Q&A

*Places are strictly limited. Register early to secure your spot.

Resources:

Flowchart - Is My Software Regulated?

https://www.tga.gov.au/sites/default/files/my-software-regulated.pdf

Software-based Medical Device Exclusions

https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/overview/software-based-medical-device-exclusions

Digital mental health tools (DMHTs)

https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/overview/types-software-based-medical-devices/digital-mental-health-tools-dmhts

Understanding digital mental health device rules

https://www.tga.gov.au/resources/guidance/understanding-digital-mental-health-device-rules

Contact the host of SaMD Regulation by the TGA: Digital Mental Health Tools

There were 0 errors found in the information you submitted: