UDI consultation paper 3: Detailed considerations for implementing the proposed Australian medical device UDI Regulatory Framework

Closed 11 Oct 2022

Opened 31 Aug 2022

Contact

UDI Support Team

02 6289 8557

udi@health.gov.au

Feedback updated 12 Apr 2023

We asked

Between August and October 2022, the TGA sought feedback on the proposed intent for the Australian UDI system. The consultation principally sought feedback on five key areas:

  • scope – the device classes that would be required to comply with the UDI requirements
  • regulatory harmonisation and burden – feedback on Australian-specific requirements and the impact on manufacturers and sponsors, and where possible, helping to identify the preferred areas of alignment with the European Union (EU) and the United States Food and Drug Administration (US FDA) regulations
  • the Australian UDI database and data provision – feedback on the proposed AusUDID data elements, what data elements would trigger a new UDI record if changed and the responsibilities for sponsor and manufacturers in providing and maintaining the Australian UDI data
  • UDI related fees and charges – feedback on how the TGA should integrate UDI into its fees and charges model; and
  • implementation timing – considerations for when the UDI would be implemented in Australia.

You said

84 submissions were received, with most representing medical device sponsors or manufacturers. Other respondents included industry peak bodies, health professionals, a clinical quality registry, a state health organisation, and other international governments. No submissions were received from General Practitioners, export-only Australian manufacturers, or consumers.

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 future policy decisions by the Australian Government. In line with your strong feedback about ongoing engagement, the TGA will continue to work closely with stakeholders as we progress the implementation.

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. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA has issued this consultation paper as part of the Government’s reform program.

This consultation paper is the third consultation paper published by the TGA relating to the Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on the two previous consultation papers, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia, and Consultation: Exploring options for the introduction of an Australian Unique Device Identification (UDI) System. Respondents may wish to consider those papers and the feedback / outcomes prior to responding to this current consultation. 
These are available via links or to download at the bottom of this page.

Why your views matter

Changes to the Therapeutic Goods Act 1989 were passed by the Australian parliament in February 2021, to allow for the establishment of the UDI database and the introduction of related requirements. For the system to be operational, there is a need to provide for the establishment of the UDI database and for setting out of related requirements, in the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

This third consultation relates to the details of the proposed regulatory framework, including seeking feedback on:

  • the impact of accepting both European and USA compliant labels
  • acceleration of delivered benefits through a phased implementation approach
  • scope and exemptions in applying the UDI
  • providing and maintaining data over the full life of the device
  • UDI related fees and charges
  • UDI labelling and supporting documentation
  • any potential regulatory burden
  • adoption and use in the broader healthcare setting

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 email or post at the following addresses:

UDI Project
c/o Medical Devices Surveillance Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

udi@health.gov.au

To do this, please download the the Cover Sheet and MS Word version of the consultation paper to use as a template for your response. 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 Australian Government for consideration.

Audiences

  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • 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