ANDHealth and the Therapeutic Goods Administration (TGA) have extended their partnership to support digital health companies with regulatory information, advice and support relating to Software as a Medical Device for a further 12 months.

Since the partnership began in September 2021, ANDHealth has aided 2,075 Australian innovators in navigating Australia’s Software as a Medical Device (SaMD) regulatory frameworks, through individual “Office Hours” sessions and monthly webinars. ANDHealth has delivered 475 personalised meetings and facilitated 40 webinars, answering hundreds of live questions with the TGA.

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

  • 99% reported an increased ability to navigate SaMD or digital health product regulations after their session
  • 99% rated the “Office Hours” as either extremely valuable or very valuable
  • Excellent NPS score of 86 across the 475 one-on-one “Office Hours” sessions

Bronwyn Le Grice, CEO of ANDHealth, welcomed the TGA’s decision and emphasised the importance of the continued partnership.

“Australian innovators are at the forefront of developing world-leading software-based and software-enabled medical technologies. Extending our collaboration with the TGA allows us to provide ongoing, expert support to help these companies bring safe, effective, and innovative products to market,” Ms Le Grice said.

“The response from the sector has been overwhelmingly positive, proving that accessible, practical regulatory support truly helps accelerate innovation and deliver real health outcomes.”

Tracey Duffy, First Assistant Secretary, Medical Devices & Manufacturing Quality Division at the TGA, said the program continued to grow in importance alongside the rapidly advancing digital health sector, including the use of AI, requiring businesses to have an understanding of the applicable regulatory requirements.

“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 consumers and health professionals who use them,” Ms Duffy said.

“ANDHealth is a critical partner to the TGA, providing unparalleled expertise and specialised training which empowers digital health innovators to navigate the regulatory pathways effectively and bring high-quality medical software to market safely and efficiently.”

The extended program continues to provide unrivalled access to regulatory experts from both ANDHealth and the TGA, fuelling the growth of Australia’s digital health sector. Companies developing software-based of software-enabled solutions are encouraged to register for upcoming Office Hours or monthly webinars.

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Learn more about the program