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TGA AI Medical Device Regulation: Preparing for 2026-2027 Enforcement in Australia
Australia's Therapeutic Goods Administration (TGA) has issued new guidance clarifying when AI-enabled software is regulated as a medical device (SaMD). This episode breaks down the TGA's focus on intended purpose, the specific evidence required for safety and performance, and why SaMD has been designated a key compliance and enforcement priority for 2026-2027. We outline the practical steps manufacturers must take now to review their product classification, update technical documentation, and prepare for increased regulatory scrutiny in the Australian market. Key Questions: - When does the…
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