7 Sep | SaMD Regulation for Clinical Decision Support Software Companies with the Therapeutic Goods Administration

September 7, 2022

Join ANDHealth and expert speakers from the TGA to hear an overview of the SaMD regulations for Clinical Decision Support Software, and participate in a live Q&A session with the TGA. This webinar is a targeted session for companies developing Clinical Decision Support Software solutions.

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

These are important sessions to attend for all Australian digital health SMEs required to comply with the current regulations, and 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 and provide feedback to the TGA.

These sessions are running again this year, after high demand from those who missed out on last year’s booked out events. So register early; don’t miss out.

For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices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

Session format

  • Regulatory overview
  • Live Q&A

Sign up for session time below:

  • Wednesday 7 September 2022 11:00am – 12:00pm (AEST)

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