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The Australian Government is strengthening patient safety by introducing Unique Device Identification (UDI) for medical devices. UDI supports other medical device reforms designed to improve the effectiveness of the regulatory framework, including the management of post-market safety-related activities, such as recalls.
With the introduction of UDI, Australia will join a globally harmonised approach that supports more accurate tracking and tracing of medical devices (unless the device is exempt).
For UDI labelling and packaging requirements and information see Unique Device Identification (UDI) hub.