A joint initiative between ANDHealth and the Therapeutic Goods Administration (TGA) will continue providing 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.

ANDHealth CEO and Managing Director Bronwyn Le Grice said: “This joint initiative between ANDHealth and the TGA will enable another 400 digital health industry participants to accelerate the commercialisation of new health products, by accessing direct advice and training about the regulatory parameters pertaining to their clinical grade medical software.”

“Thanks to the support of the TGA, hundreds more emerging technology businesses will get access to regulatory training and support,” Ms Le Grice said.

“Clinical-grade software as a medical device is increasingly making a sizeable impact in patients’ lives, improving health outcomes through enhanced diagnosis, treatment and management of diseases, and other health issues,” she said.

The new partnership includes 10 virtual workshops 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.

First Assistant Secretary, Medical Devices & Manufacturing Quality Division of the TGA, Tracey Duffy, said: “Now more than ever, with the growing use of artificial intelligence, we need to support businesses who are developing software products. ANDHealth is a critical partner helping to raise awareness and understanding of the regulations that aim to safeguard consumers, patients and health professionals and the performance of these products.”

Software based medical devices are medical devices that incorporate software or are software, excluding health and lifestyle apps.

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.