Australia’s leading digital health commercialisation organisation, ANDHealth, has today announced the extension of its partnership with the Therapeutic Goods Administration (TGA) to provide ongoing regulatory guidance to Australia’s rapidly growing digital health and software-enabled sector.

The program will include 10 webinars to 20-40 attendees 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, which will allow them to accelerate the commercialisation of their products.

Since September 2021, ANDHealth and the TGA have supported over 380 companies and delivered webinars and coaching to over 800 participants to increase their understanding of the regulatory requirements for digital products entering the Australian market. The new agreement is anticipated to allow support for another 350 digital health companies.

ANDHealth CEO and Managing Director Bronwyn Le Grice said: “Our partnership with the TGA provides critical support to SMEs seeking to ensure that they are operating within the regulatory frameworks, which exist, first and foremost, to protect patients.”

“Innovators in health must operate to a higher standard as they hold the health of their users in their hands. By providing this support to our innovator community, ANDHealth and the TGA are working to ensure safe and evidence-based technologies are placed into the hands of consumers, and I am delighted to see it extended for a further year,” Ms Le Grice said.

The announcement is in response to growing levels of investment from global governments, pharmaceutical companies, and healthcare providers in digital health software solutions and an increased focus from regulators on the clinical claims made by these new innovations.

Deputy Secretary of the TGA, Professor Tony Lawler said: “The TGA is pleased to continue the close partnership with ANDHealth to provide training, support and assistance to industry in understanding how medical device regulation applies to software based or enabled medical devices. The extension of this partnership with ANDHealth will enable us to deliver continued industry-wide education and communications, such as webinars and SaMD dedicated 1-1 office hours over the next 12 months, to complement the TGA’s other communication activities. The TGA encourages companies and individuals to benefit from ANDHealth’s program of webinars and office hours sessions, and also to not hesitate to reach out directly to the TGA if wished.”

Since the partnership was forged in 2021, demand for live training remains high, with 100% of the ANDHealth-TGA webinars fully booked out and 91% of attendees confirming the webinar increased their knowledge of SaMD regulation.

Of the over 200 SaMD office hour meetings delivered, 98% of participants agreed that the one-on-one coaching they received increased their ability to navigate either the SaMD regulations or the regulations pertaining to their digital health solution, or both, with 98% finding the sessions extremely or very valuable.

This training includes understanding the scope of digital 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.

Feedback from industry participants in the previous program has been overwhelmingly positive:

“Essential service to support the industry in developing SaMDs.”

“The office hours meeting provided much needed clarity around our regulatory strategy and how this can work alongside out commercial objectives.”

“The session was very informative and valuable to us. Would highly recommend to any medical software company.”

For more information about ANDHealth’s partnership with the TGA, visit www.andhealth.com.au/partners/tga.