TGA Post-Market Requirements – Responsibilities of SaMD Manufacturers and Sponsors

Join ANDHealth and expert speakers from the TGA to hear an overview of the post-market requirements and responsibilities of SaMD manufacturers and sponsors and participate in a live Q&A session directly with the TGA.

This joint TGA-ANDHealth initiative will support Australian SMEs to navigate the regulatory guidelines and compliance requirements for Software as a Medical Device (SaMD).

This is an important session to attend for all Australian digital health SMEs 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 by the TGA.

Session format:

Regulatory overview
Live Q&A

Sign up for the next session:

Wednesday 9th August 10:00 am – 11:00 am AEST

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For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices|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