Complying with the Unique Device Identification requirements for medical devices

Purpose

We have prepared this guidance to help you as a sponsor or manufacturer understand your regulatory obligations under Australian therapeutic goods legislation. Specifically, this information covers:

• medical devices and in vitro diagnostic (IVD) medical devices in scope of the Unique Device Identification (UDI) regulations
• UDI labelling requirements
• data submission requirements
• specific device requirements.

This document outlines the requirements to get and apply a UDI and submit and maintain UDI data in the Australian UDI Database (AusUDID).

Information about UDI compliance dates is not included in this document. We have prepared a separate guidance to help you as a sponsor or manufacturer understand how to comply with the Unique Device Identification timeframes for medical devices. Specifically, this information covers:

• voluntary compliance
• mandatory compliance
• transition periods for existing devices
• transition periods for European Union (EU) certified devices.

For this Guidance:

• we refers to the Therapeutic Goods Administration (TGA)
• you refers to sponsor or manufacturer of medical devices or IVD devices
• medical devices refers to both medical devices and IVDs
• UDI record refers to a UDI-DI and related data published as a record to the Australian Unique Device Identification Database (AusUDID)
• devices in scope of UDI requirements refers to devices that are of a risk classification that must meet UDI requirements and are not otherwise exempt.

For a full list of definitions used throughout this document, see Appendix C.