16 Nov | Regulation and Oversight of Digital Mental Health with the Therapeutic Goods Administration

November 16, 2022

Join ANDHealth and expert speakers from the TGA and the Australian Commission on Safety and Quality in Health Care to discuss the regulation and oversight of digital mental health software and services.

The TGA has been working with the Commission and other parts of the Australian Government Department of Health to ensure the safety and performance of digital mental health tools and services while balancing the need to minimise regulatory burden.

This webinar is targeted at digital mental health service providers/clinicians/SMEs and developers of digital mental health software. Seats will be limited so please only register if this topic is relevant to you. We will be running another general overview of Software as a Medical Device (SaMD) regulation later in November.

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 a factsheet regarding the regulation of digital mental health software, please visit: https://www.tga.gov.au/sites/default/files/digital-mental-health-software-based-medical-devices.pdf

For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices

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

Session format

  • Regulatory overview
  • Live Q&A

Webinar: Regulation and Oversight of Digital Mental Health

  • 11am – 12pm (AEDT)
  • Wednesday 16 November 2022

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