Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: UDI consultation paper 2

Overview

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia.  As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms.  We have issued this consultation paper as part of the reform program.

This is the second consultation paper published by the TGA relating to the proposed Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on the first consultation paper, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia. We recommend that respondents read the first consultation paper prior to considering this second consultation paper.

Why We Are Consulting

In January 2019 the TGA consulted on a proposal to introduce a Unique Device Identification (UDI) System for medical devices in Australia.  The rationale for a UDI was set out in this first paper, including the benefits to patient safety.

There was a strong consensus across all stakeholder groups for the need to introduce the UDI system in Australia. The majority of respondents also considered that the TGA should be responsible for establishing and managing the AusUDID, and that it should be linked to the Australian Register of Therapeutic Goods (ARTG), as well as other databases.

As a result, the TGA will undertake a series of consultations to inform the planning and design of a potential Australian implementation.  Each consultation will be designed to cover key topic areas that we will need to consider as we progress with our planning.  The consultation process is anticipated to include consultation papers, stakeholder workshops and discussions, and we will engage broadly across the health system – from supply, procurement and distribution through to clinical use, patients and consumers, registries and the use of device information for post-market analysis and research.

These consultations will inform the policy decisions that will be made by the Australian Government.

In this second consultation we are seeking your views on:

1. What are the benefits of an Australian UDI System across the broader health system?
2. Should the first phase of an Australian implementation be limited to a small number of high-risk devices?
3. If the Australian implementation fully aligns with the IMDRF guidance what will the impact be?
4. What mechanisms should be considered for submitting the UDI data to the TGA?
5. What might the benefits be for implementing the EU Basic UDI-DI in Australia?
6. What are the benefits of the Global Medical Device Nomenclature (GMDN) and how is it being used?

We invite you to complete our online survey (click on the link below).

If you prefer, you can make a submission directly to the Department via post or email at the following addresses:

Medical Devices Reform Unit
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

devicereforms@tga.gov.au

If you choose to do this, you may download the MSWord version of the consultation paper to use as a template for your response.  Please also download and complete a copy of the Cover Sheet.  Both are available via links at the bottom of this page.