Australia’s TGA has released a 2025 compliance update clarifying how AI and software-based tools, such as digital scribes with diagnostic or treatment functions, may fall under medical device regulations. Developers must assess whether their products require inclusion in the ARTG and ensure compliance to avoid enforcement action.
The Therapeutic Goods Administration (TGA) 2025 compliance update highlights a growing focus on AI and software-based medical devices in Australia. Under the Therapeutic Goods Act 1989, some advanced AI tools—including digital scribes that suggest diagnoses or treatments—may be regulated as medical devices. Developers and suppliers must ensure compliance, including registration in the Australian Register of Therapeutic Goods (ARTG) where required.
The TGA is working closely with industry to:
AI Digital scribes are increasingly moving beyond transcription, adding features like diagnostic support and treatment recommendations. These functions may bring the software within the scope of medical device regulation, requiring ARTG inclusion before advertising or supply.
Where non-compliance is suspected, the TGA may take targeted regulatory action. This ensures patient safety while maintaining a fair and innovative environment for digital health solutions.
TGA’s 2025 compliance update covers AI and software-based medical devices under the Therapeutic Goods Act 1989. Tools like AI scribes may qualify as medical devices if they provide diagnostic or treatment suggestions. Such products must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempt. The TGA encourages voluntary compliance and may take enforcement action where unlawful advertising or supply is identified.
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