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Digital & Innovation

Regulatory guidance for digital health industry to accelerate commercialisation of new innovations

Health Industry Hub | August 25, 2021 |
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Digital & Innovation: Australia’s leading digital health commercialisation organisation, ANDHealth, announced a partnership with the Therapeutic Goods Administration (TGA) to support Australia’s digital health companies navigate the regulatory environment for ‘software as a medical device’ (SAMD).

The Government implemented reforms to the regulation of software based medical devices to clarify the boundary of regulation, reduce or remove unnecessary regulatory burden and align more closely with international frameworks. The guidance came into effect from 25 February 2021.

This initiative will build the capability of Australian SMEs to design and deliver robust clinical trials and evidence to support the safety and efficacy of digital health products.

Bronwyn Le Grice, CEO and Managing Director of ANDHealth, said “Having a strong regulatory environment for digital heath products not only provides access to safe, evidence-based digital health products to improve patient outcomes, but also improves the commercial potential of new innovations.”

(SAMD) are software products that typically diagnose, monitor, specify or recommend treatment to consumers or health professionals. The regulatory framework is technology agnostic, meaning that the software may be in the cloud, an app, a web app, or a website.

ANDHealth will deliver a series of interactive webinars, live Q&A and feedback sessions alongside customised 1-1 coaching on SAMD considerations.

“A sound understanding of the regulatory environment will support our digital health innovators and entrepreneurs build an internationally competitive digital health sector, including the distinctions between evidence-based digital health products and digital therapeutics and general consumer wellness products,” said Bronwyn.

“We are delighted to partner with the TGA to help Australia’s emerging and innovative digital health companies navigate the regulatory landscape for software-based digital health products. The TGA has played a critical role in helping shape the Government’s current framework through a two-year consultation with industry. From September 2021, we can complement the TGA’s efforts with industry and we applaud the TGA for their ongoing commitment to industry consultation,” said Bronwyn.

Adj Prof. John Skerritt, Deputy Secretary, and head of the TGA said “The TGA is pleased to be working with ANDHealth to provide these additional channels of communication and education to complement TGA’s existing interactions with the sector. Companies are encouraged to leverage ANDHealth’s expertise and offerings, as well as to continue to contact the TGA directly if desired.”

ANDHealth and the TGA are hosting the first session Tues 7th September 10-11am. More information can be found here.


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