Australia has introduced the most significant overhaul of vehicle lighting regulations in decades. The Vehicle Standard (Australian Design Rule) Vehicle Lighting Amendment 2026 (F2026L00854) modernises lighting requirements, aligns Australia with simplified UN regulations, and introduces four new ADRs specifically designed for LED and modern lighting technologies. These changes affect every vehicle category, every lighting component, […]

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Australia has introduced mandatory Unique Device Identification (UDI) requirements for medical devices, marking one of the most significant regulatory changes in recent years. The new UDI framework strengthens device traceability, improves post‑market surveillance, and aligns Australia with global systems such as the FDA GUDID and EU MDR/IVDR UDI frameworks. This guide explains the new TGA […]

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Achieving ISO certification is a major milestone for any organisation. It signals maturity, reliability, and a commitment to quality, safety, and environmental responsibility. But one factor is often overlooked — the suitability of the certification body auditor assigned to your audit. Not all auditors are the same. Their background, industry experience, technical understanding, and risk […]

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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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