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

Closed 24 Dec 2020

Opened 23 Sep 2020

Feedback updated 19 May 2021

We asked

Between September and December 2020, the TGA sought feedback to help inform the planning and design of the implementation of identifiers for Australian medical devices and the establishment of the Australian Unique Device Identification database. This is the second consultation and builds on the findings from the first. Specifically the TGA sought feedback 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?

You said

Ninety responses were received with sixty percent of responses from medical device manufacturers and/or sponsors. The remaining respondents represent most other segments of Australia’s healthcare system, however it was noted that no submissions were received from Registries or General Practitioners.

Respondents provided wide-ranging comments and suggestions across all questions. Overall, the responses demonstrate continued strong support for the Australian implementation as well as many valuable comments and suggestions on the implementation approach and phasing.

The TGA appreciates all the feedback and thanks all respondents.

We did

We have analysed all responses and the results will inform Australian Government policy decisions going forward. In line with your strong feedback on ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.

Results updated 19 May 2021

Introduction

The TGA thanks respondents who submitted a response to the public consultation paper, Exploring options for the introduction of an Australian Unique Device Identification (UDI) System: consultation paper 2, which closed on 24 December 2020.

Ninety responses were received with sixty percent of submissions from medical device manufacturers and/or sponsors. The remaining respondents represent most other sections of Australia’s health system. However, it was noted that no submissions were received from Registries or General Practitioners.

Summary of responses and Analysis of submissions received

Overall, responses continued to demonstrate strong support for the implementation of an Australian UDI Database and its role in enabling benefits across the broader healthcare system including for patients, hospitals, healthcare practitioners, governments and regulators.

Some smaller Australian manufacturers of low-risk Class I (non-sterile, non-measuring) devices, while supporting an Australian UDI, were concerned with the impact and increased burden and cost to their businesses.

Respondents expressed strong support for both the manufacturer and the sponsor having a role in providing the data for an Australian UDI, with most respondents seeking the capability for bulk upload and download of data via an electronic interface offered by the TGA. Many asked for the TGA’s data exchange method to be similar to the U.S. FDA system, which gives manufacturers / sponsors the ability to enter data into a “sandpit” environment where they update and confirm the UDI data before it is officially recorded against a medical device.

A period of twelve months is the preferred lead-time between the publishing of the regulations and when the UDI becomes mandatory – this was considered the minimum period necessary for organisations to prepare their people, business processes and ICT solutions.

Respondents had strong views both for and against Australia’s adoption of the European Union (EU) Basic UDI Device Identifier (Basic UDI-DI). Almost half considered Basic UDI-DI could provide another means for device grouping and create different UDI associations with product recalls, adverse events or other post market analysis. Others argued it would not provide additional benefit as the Australian Register of Therapeutic Goods (ARTG) identifier serves a similar purpose and the EU system is not yet operational nor globally harmonised.

There was specific feedback on the compliance impact to manufacturers and sponsors that supply to multiple markets, all of which are implementing a UDI framework. Respondents were equally divided on whether Australia should align with the U.S. FDA or the EU.

Almost half of the respondents raised concerns with a phased implementation, arguing that a Limited First Phase would extend the overall implementation timeframe, increase the cost and risk of managing devices between jurisdictions and take longer to realise benefits.

To address this, respondents suggested extending the Limited First Phase to include all U.S. manufactured and Australian supplied devices that are present in the U.S. FDA’s Global Unique Device Identification Database (GUDID). They suggested this approach could help Australia introduce UDI faster and limit the impact on many U.S. manufacturers because their systems and processes would already cater for a UDI.

Proponents of this accelerated approach acknowledged that harmonising Australia’s system with the U.S. FDA and EU was the long-term goal. They suggested that the TGA could commence its initial activities using U.S. FDA data and rules (as it is operational) with the EU rules folded in when they are operational.

A high proportion of respondents expressed a strong interest in continuing to participate in the TGA’s ongoing design and implementation activities, either as members of a Working Group or through ongoing communication and support activities.

Next steps

We have analysed all responses and the results will inform Australian Government policy and regulatory drafting decisions. The TGA will continue to work closely with stakeholders as we progress the implementation and we appreciate the feedback and thank all respondents.

Published responses

View submitted responses where consent has been given to publish the response.

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.

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise in the survey or submission form).

Outcomes from the consultation will be provided to the Government for consideration.

Audiences

  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Local governments
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Contracted Service Providers
  • Medical Devices & IVDs
  • Other

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Medicare
  • Legislation
  • Pharmaceutical benefits
  • Health insurance
  • Regulatory policy
  • Strategic Policy
  • Policy Development