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TGA

23 April 2026

TGA consults on predetermined software changes

The Therapeutic Goods Administration (TGA) has opened consultation on a draft guidance document outlining how predetermined change control plans, or…
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1 April 2026

Jailbreak testing essential for AI providers – expert

AI providers, including those in healthcare, should be undertaking stringent jailbreak testing of their software to avoid data and privacy…
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9 March 2026

AI clinical decision support enters TGA regulatory pathway

Botaniqal Clinics Australia has submitted its AI-enabled clinical decision support software, ROSE, to the Therapeutic Goods Administration for registration as…
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23 February 2026

Alcidion clears path for AI-enabled workflows

Alcidion’s Miya Precision Concept Detection has been included on the Australian Register of Therapeutic Goods as a Class 1 Medical…
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27 November 2025

Ireland’s Living Registry a blueprint for connected cardiac care in Australia

OPINION: How a national data infrastructure transformed cardiac safety, compliance and clinical efficiency, and why Australia is primed to follow.…
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20 November 2025

TGA seeks feedback on digital mental health tools

The Therapeutic Goods Administration (TGA) is reviewing regulations around software-based medical devices – including digital mental health tools (DMHTs) –…
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3 September 2025

TGA sets focus on AI compliance, clarifies status of scribes

The Therapeutic Goods Administration (TGA) says it is “stepping up” its efforts to ensure that software-based medical devices meet Australia’s…
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18 August 2025

ANDHealth extends SaMD support

ANDHealth and the Therapeutic Goods Administration (TGA) have extended their partnership to support digital health companies with regulatory information, advice…
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27 May 2025

Engage with us early on AI, says TGA

Suppliers of AI technologies in healthcare should identify early on whether they need TGA approval, while users should look for…
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24 August 2022

Phenix Health rebrands smoking cessation website after TGA slap

Telehealth platform Phenix Health has rebranded its smoking cessation website after the Therapeutic Goods Administration (TGA) issued a warning that…
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