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Date: Thursday 15 October 2026
Time: 2:00 pm – 3:00 pm (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
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
This webinar 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!
