ANDHealth has announced the renewal and expansion of its partnership with the Australian regulator, the Therapeutic Goods Administration (TGA), as its core industry outreach, training and education partner for Australian Software as a Medical Device (SaMD) regulation for a further 12 months.

The renewed partnership will see ANDHealth continue to deliver national, no‑cost access to expert guidance on SaMD regulation, helping innovators accelerate the safe and effective commercialisation of new digital health technologies, including those harnessing the rapidly increasing capabilities of artificial intelligence.  

The renewal of the ANDHealth – TGA partnership comes at a pivotal moment for Australia's digital health sector. The TGA’s regulatory approach is technology-agnostic basis, focusing on a technology’s intended purpose rather than the technology it utilises. However, with software as a medical device (SaMD) expressly including artificial intelligence, innovators building in frontier technology domains need to consider their regulatory strategy early in the development lifecycle.  

As AI moves from the margins to the mainstream of new health technologies, a growing share of the evidence-based digital and connected health technologies ANDHealth works with now sit squarely within the TGA’s regulatory framework. This partnership strengthens ANDHealth's ability to help startups navigate SaMD and AI regulation with confidence, embedding regulatory readiness into our national commercialisation programs and reinforcing Australia's sovereign capability to bring safe, effective, world-class digital health technologies to market and to the world.  

ANDHealth's services now cover all software-based medical devices regulated by the TGA, including Software as a Medical Device (SaMD) — standalone digital products such as apps, AI tools, and cloud-based clinical software.

Since the partnership began in August 2021, ANDHealth has supported over 2,300 Australian innovators in navigating Australia’s Software as a Medical Device (SaMD) regulatory frameworks, through individual “Office Hours” sessions and sold-out webinars.  

Over this time, ANDHealth has delivered 595 personalised one-on-one “Office hours” meetings and facilitated 45 webinars, answering hundreds of live questions with the TGA.

Key program outcomes to date, based on survey responses from participants, include:  

  • 100% reported an increased ability to navigate SaMD or digital and connected health product regulations after their session
  • 99% rated the “Office Hours” as either extremely valuable or very valuable  
  • Excellent NPS score of 85 across the one-on-one “Office Hours” sessions

Bronwyn Le Grice, CEO of ANDHealth, welcomed the renewal and expansion and emphasised the importance of the continued partnership.

“Australian innovators continue to lead the world in developing world-leading software-based and software-enabled medical technologies, from wearable sensors to digital biomarkers and AI-powered diagnostics and platforms,” Ms Le Grice said.  

“Renewing our partnership with the TGA provides companies with invaluable insight and support in establishing an effective regulatory strategy and improves industry-wide understanding and capabilities in navigating SaMD regulation.”

“The feedback from the sector has been consistently strong, with innovators telling us that the combination of targeted one‑to‑one advice and practical, interactive webinars gives them the confidence to engage with regulation early, design their products to meet requirements, and ultimately move faster towards patient and market impact.”  

Tracey Duffy, First Assistant Secretary, Medical Devices & Manufacturing Quality Division at the TGA, said the renewed partnership reflects the growing importance of SaMD regulation in a rapidly evolving digital and connected health sector.

“The Office Hours and webinar program has clearly met a critical need for digital and connected health innovators navigating regulatory processes, ensuring their products meet rigorous safety and performance standards expected by the consumers and health professionals who use them,” Ms Duffy said.  

“ANDHealth plays a pivotal role as a trusted partner of the TGA, delivering deep, specialised expertise and practical training that supports digital and connected health innovators to confidently navigate regulatory pathways and bring high‑quality medical software to market safely and efficiently.”

The extended partnership continues to provide access to regulatory experts from both ANDHealth and the TGA, supporting the growth of Australia’s digital and connected health sector, which has grown at a compound annual growth rate (CAGR) of 55% since 2018.

Companies developing software-based of software-enabled solutions are encouraged to register for upcoming Office Hours or monthly webinars. Information is available here.

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