SaMD Regulation by the TGA: Clinical Decision Support Systems (CDSS)

SaMD Regulation by the TGA: Clinical Decision Support Systems (CDSS)

Join ANDHealth and the TGA on Tuesday 24 March for a focused webinar on Australian regulations governing CDSS - clarifying definitions, understanding how TGA regulates CDSS, the exemption criteria and when CDSS is and is not 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 24 March 2026

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

• For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices|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