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TGA sets focus on AI compliance, clarifies status of scribes

3 September 2025
By Reesh Lyon
The Therapeutic Goods Administration (TGA) says it is “stepping up” its efforts to ensure that software-based medical devices meet Australia’s regulatory requirements – including devices using artificial intelligence (AI). The TGA says it is currently “working closely” with industry to encourage voluntary compliance; provide clear and consistent guidance; respond to complaints and reports of non-compliance; […]

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