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Consultation: Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia

7 January 2019

This consultation closed on 18 February 2019.

Demand is growing for improved traceability of medical devices in the supply chain. There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential. The development and implementation of the Unique Device Identification System (the UDI System) is widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices.

We are exploring the feasibility of introducing the UDI System in Australia, including options for development of the UDI database (AusUDID), and sought your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia. Your input will assist us to address any unintended consequences and to better inform the proposal.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Monday, 7 January 2018.

Interested parties should respond by close of business Monday, 18 February 2018.

Feedback will be released following consideration of submissions (see 'What will happen').

Content of submissions

Submissions must be relevant to the proposed amendments and questions detailed within the consultation paper.

In addition, submissions may include information on:

  • Suggested improvements.
  • Whether or not you support the proposals, including suggestions for alternatives.
  • An assessment of how the proposal will impact on you.

Members of peak industry bodies that the TGA held bilateral meetings with (listed in the consultation paper) are encouraged to present their comments through the respective peak body so that the industry body can present a consolidated industry feedback to the TGA.

Enquiries

Any questions relating to submissions should be emailed to devicereforms@health.gov.au.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group)
    • seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.