SaMD Regulation by the TGA: Software-based Medical Device Exclusions

SaMD Regulation by the TGA: Software-based Medical Device Exclusions

Join ANDHealth and the TGA on Tuesday 25 August for a focused webinar on software-based medical device exclusions. We will unpack how software fits into the definition of a medical device and demystify what types of software are - and are not - regulated by the TGA.

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 questions on regulations and exclusions answered!

WEBINAR DETAILS

Date: Tuesday 25 August 2026

Time: 11:00am - 12:00pm AEST

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