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Date & time:
Wednesday 9 Aug 2023
10:00 am – 11:00 am (AEST)
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For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices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
For the latest Australian regulatory guidelines for medical devices (ARGMD): https://www.tga.gov.au/resources/resource/guidance/australian-regulatory-guidelines-medical-devices-argmd
Join ANDHealth and expert speakers from the TGA to hear an overview on 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.
