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 Thursday 15 October 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 will also cover the CDSS amendments which come into force on the 1st of November and are intended to provide greater clarity about when the exemption applies. The amendments do not change the scope of the CDSS exemption or introduce new regulatory requirements.

Come along to have your regulatory questions answered!

WEBINAR DETAILS

Date: Thursday 15 October 2026

Time: 2:00pm - 3:00pm 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
• 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-ai/manufacturing/artificial-intelligence-ai-and-medical-device-software-regulation