SaMD Regulation with the Therapeutic Goods Administration (TGA)

An Overview: SaMD Regulation by the TGA

Join ANDHealth and expert speakers from the TGA to hear a comprehensive, real-world case study on navigating the an overview of the key changes in the updated SaMD regulations. Our presenters will illustrate how the regulations can apply to a particular case, after which 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 the 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 answered!

Session format:

• Regulatory overview
• Live Q&A

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For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices|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