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The Australian Unique Device Identification (UDI) system supports accurate medical device identification and forms broader reforms to strengthen medical device regulation.
UDI can:
- improve the traceability of medical devices
- support the management of safety-related activities
- enable faster responses to recalls, safety alerts and adverse events.
Australia's UDI system aligns, where possible, with international approaches to help improve the consistency and quality of device information while reducing regulatory complexity for industry.
The Australian UDI system is being implemented over 5 years, starting with higher-risk devices and progressively extending to lower-risk devices.