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TGA Med. Dev Guidance: Unique Device Identification (UDI) Compliance for Medical Devices in Australia
The Australian Therapeutic Goods Administration (TGA) has updated its guidance on the implementation of the Unique Device Identification (UDI) system for medical devices supplied in Australia. The guidance, Complying with the Unique Device Identification Timeframes for Medical Devices, Version 2.0, published in May 2026, explains the phased UDI compliance timelines, sponsor responsibilities, transitional arrangements, and direct marking obligations for medical devices and IVD
Sharan Murugan
11 hours ago3 min read