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Date & time:
Wednesday 14 June 2023
11:00 am – 12:00 pm (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For the current draft guidance, please visit: https://www.tga.gov.au/regulation-software-based-medical-devices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
Join ANDHealth and expert speakers from the TGA to hear an overview of the key changes in the updated SaMD regulations, 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 and provide feedback to the TGA.
