The joint TGA-ANDHealth initiative supports Australian SMEs to navigate the regulatory guidance and compliance requirements for Software as a Medical Device (SaMD).
Since September 2021, ANDHealth and the TGA have supported 192 companies to increase their understanding of regulatory requirements, including the type of evidence required when seeking regulatory approval by the TGA, when regulatory approval is not required, how to list a device on the Australian Register of Therapeutic Goods (ARTG) and the differences between Australia and other international markets.
The extended partnership will see TGA fund ANDHealth to deliver industry-wide training to over 350 participants from the Australian digital health sector in the next 12 months. The program includes 10 virtual workshops and over 150 hours of direct one-to-one coaching for digital health SMEs seeking to navigate Australia’s Software as a Medical Device (SaMD) regulatory environment, supporting them to accelerate the commercialisation of their products.
“Our partnership with the TGA puts Australia’s emerging digital health innovators in the best position to effectively navigate the regulatory environment and pursue clinical programs that make their ground-breaking health technologies globally marketable.”
– Bronwyn Le Grice, CEO and Managing Director, ANDHealth
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