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UDI compliance timeframes

Learn when Unique Device Identification (UDI) requirements become mandatory for medical devices and in vitro diagnostic (IVD) medical devices supplied in Australia.

UDI requirements are being introduced in stages, starting with higher-risk medical devices and progressively extending to lower-risk devices. 

Use these resources to determine when UDI requirements apply to your devices and plan for compliance. 

Determine when UDI applies to your device

Use the decision tool to determine when UDI requirements become mandatory for the devices you supply in Australia.

Understand UDI compliance timeframes

UDI requirements do not apply to all devices at the same time. Compliance dates vary depending on factors such as:

  • whether the device is a medical device or an IVD medical device
  • the classification of the device
  • applicable transition arrangements
  • any exemptions or special circumstances

Review the compliance timeframe guidance to understand when UDI requirements take effect.