SaMD Regulation with the TGA: Digital (AI) Scribes

Join ANDHealth and the TGA on Tuesday 26 May for a focused webinar on Australian regulations governing digital (AI) scribes, including key definitions, how the TGA approaches their regulation, and when a digital scribe is (and is not) classified as a medical device.

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 26 May 2026

Time: 12:00pm - 1:00pm AEST

Where*: Online via Zoom Webinar

Registration**: Free to attend, but registration essential

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

*This webinar will not be recorded. Attendance at the live webinar is required to access content.

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

Resources:

For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices|
To test out the new "Is my Software regulated" flow chart, please visit: https://www.tga.gov.au/sites/default/files/my-software-regulated.pdf
For guidance on the Exclusions and Examples of regulated and unregulated software (excluded) software-based medical devices, please visit: https://www.tga.gov.au/sites/default/files/examples-regulated-and-unregulated-software-excluded-software-based-medical-devices.pdf
For guidance on Classification of active medical devices including software-based medical devices: https://www.tga.gov.au/resources/resource/guidance/classification-active-medical-devices-including-software-based-medical-devices

Contact the host of SaMD Regulation with the TGA: Digital (AI) Scribes

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