Join ANDHealth and the TGA on Tuesday 15 September for an overview of SaMD regulations in Australia.

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 15 September 2026

Time: 2:00pm - 3:00pm AEST

Where: Online via Zoom Webinar

Registration: Free to attend, but registration essential

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

*The content portion for this webinar will be pre-recorded and available to registrants post-event.

**Attendance at the live webinar is required to access live Q&A with TGA experts.

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

Clinical Decision Support System Software Regulation

https://www.tga.gov.au/resources/guidance/understanding-clinical-decision-support-system-software-regulation

AI and Medical Device Software Regulation

https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence[…]ficial-intelligence-ai-and-medical-device-software-regulation

Contact the host of An Overview of SaMD Regulation by the TGA

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