More and more Australian SMEs are building software that edges into the health space — sleep apps, symptom checkers, monitoring tools, AI‑driven insights. But the moment your software starts diagnosing, predicting, preventing, treating or monitoring a condition, you’ve crossed into medical device territory under the Therapeutic Goods Act. And once you’re in that category, your […]

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SaMD Medical Device Software

In Australia, software that meets the definition of a medical device is generally regulated by the Therapeutic Goods Administration (TGA). However, not all health‑related software is subject to full regulatory oversight. The Therapeutic Goods (Excluded Goods) Determination 2018 sets out circumstances where certain health‑related software is excluded from regulation as a medical device in Australia. […]

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