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