This joint initiative between ANDHealth and the Therapeutic Goods Administration (TGA) provides regulation and registration support for digital medical software companies looking to commercialise new products that can help improve health outcomes for Australian patients.
The highly acclaimed program has so far benefited over 1,000 industry members through 25 sold-out workshops and 350 hours of 1:1 training, with companies saying the training program has increased their ability to navigate Software as a Medical Device (SaMD) registration and regulations for new digital health technologies.
The program supports understanding the scope of products that are subject to regulation and require listing on the Australian Register of Therapeutic Goods (ARTG), software as a medical device classification, compliance with regulatory requirements and post-market responsibilities for manufacturers and sponsors of SaMD through webinars and one-on-one meetings.
The new partnership includes 10 webinars for another 200-400 attendees and over 160 hours of direct one-to-one coaching for digital health businesses seeking to navigate Australia’s SaMD regulatory environment, supporting them to accelerate the commercialisation of their products.
As well as providing support for Australian digital health companies, this program is open to researchers, clinicians, international companies looking to export to Australia, and interested parties from industry.
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