Australia's TGA regulates AI-based medical software as a medical device
According to an Australian legal overview, software that diagnoses, predicts, monitors or treats disease is a medical device under section 41BD of the Therapeutic Goods Act. Digital health startups of this kind are therefore required to register with the TGA.
Who is affected and how
- medtech company
- The intended purpose of AI software determines whether it counts as a medical device, so this must be clarified before entering the Australian market.
Sources
- Software as a Medical Device: How the TGA Regulates Digital Health and AI-Enabled Medical Software Startups in Australia | Viridian Lawyersviridianlawyers.com · Oct 6, 2026
- Is my software or AI tool a medical device? The key is in the purposepenningtons manches cooper · Oct 8, 2026
- Is my software or AI tool a medical device?penningtonslaw.com · Oct 8, 2026
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