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AUSUDID REGULATION & GUIDANCE DOCUMENTS

AusUDID Regulation & Guidance Documents

Type
Name
Version
Release Date
Archive
Australian UDI Implementation Position Paper - Final Approach for Multiple Sponsors of Same Device v1.0
v1.0
Guidance on how AusUDID will implement an approach for device registration when multiple sponsors exist for the same device.
28 Mar, 2025
Complying with the Unique Device Identification requirements for medical devices
v1.0
TGA guidance to help sponsors and manufacturers understand their UDI obligations under Australian therapeutic goods legislation
28 Mar, 2025
Complying with the Unique Device Identification timeframes for medical devices
v1.0
TGA guidance on the timeframes for supplying UDI compliant medical devices in Australia
28 Mar, 2025
Overview of Unique Device Identification (UDI) for Australian healthcare
v1.0
Overview of the main concepts of UDI and highlights the benefits of UDI adoption in healthcare provider organisations
28 Mar, 2025
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025
v1.0
Official version of UDI legislation in Australia as made available on the Federal Register
20 Mar, 2025