Complying with the Unique Device Identification timeframes for medical devices

Purpose

We developed this guidance to help sponsors and manufacturers understand and comply with Australia’s Unique Device Identification (UDI) requirements. It explains UDI compliance dates and provides practical examples for understanding the phased approach and transitional arrangements.

This guidance does not describe the general UDI requirements for medical devices and IVDs. For guidance on the UDI requirements for labelling, packaging and identifiers, see: Complying with the Unique Device Identification requirements for medical devices.

We encourage readers to review that guidance first. It provides details and explains terminology not in this guidance.