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UDI guidance documents

Read key guidance to help you understand and meet Australia’s Unique Device Identification (UDI) requirements.

Access key guidance documents that support understanding and implementation of Australia's Unique Device Identification (UDI) requirements. 

These resources explain the legislative framework, compliance obligations, and implementation timeframes for sponsors and manufacturers of medical devices and in vitro diagnostic (IVD) devices. 

Together, they provide the foundation for meeting UDI requirements.