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Brief
On 30/07/2025, the Therapeutic Goods Administration (TGA) issued an update regarding TGA AI Review. The agency published its report "Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI)", which outlined key findings from a consultation aimed at improving the TGA's legislative framework for AI in the therapeutic goods sector. Additional information related to the review will be published on the TGA website, following government approval received in January 2025.
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