Medical Devices and IVDs October 23, 2025

Medical Device Classification in Australia

OMC AdminContent Writer

Medical Device Classification in Australia

Australia’s Medical Device Classes: From Low to High Risk Explained

In Australia, medical devices are classified into four risk-based categories: Class I (low risk), Class IIa, Class IIb, and Class III (high risk). The Therapeutic Goods Administration (TGA) oversees classification and regulatory approval. Higher-risk devices require more stringent evaluation, ensuring safety and efficacy before entering the market.

Download the below PDF to get more detailed information about Different Categories of Medical Devices in Australia.

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