Australia TGA Classification Rule 5.5: Reclassification Changes for Medical Devices

Medical Device Global Market Access · Jun 30, 2026 · 5m

Australia's TGA has amended medical device classification rule 5.5, effective July 1, 2024. The change removes materials of microbial and recombinant origin from the scope of the rule, which previously mandated a Class III classification. This will lead to the down-classification of certain devices, such as some dermal fillers or surgical meshes, likely to Class IIb. Sponsors of existing devices on the ARTG must submit a reclassification application before the critical deadline of July 1, 2026, to continue supplying their products in Australia. Key Questions: - What specific changes did the…