UDI consultation paper 3

Closed 11 Oct 2022

Opened 31 Aug 2022

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
  • 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