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Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices

13 February 2019

This consultation closes on 31 March 2019.

Invitation to comment

The Therapeutic Goods Administration (TGA) is seeking feedback on how personalised medical devices are regulated in Australia.

Over the past two decades, rapid advances in computing technology and materials science have driven exponential change in medical imaging technology, manufacturing technology, and (as a result) medical device technology. Advancing technology such as 3D printing is allowing more complex and, in some cases, higher risk medical devices to be manufactured for an individual patient, and is also allowing point of care manufacture of these personalised medical devices.

The proposed changes set out in this consultation seek to better regulate personalised medical devices, including the introduction of new definitions. The purpose of this consultation, which follows on from an earlier public consultation and public forums in 2017 and 2018, is to understand the impact that the proposed changes will have on the medical devices industry, health care professionals, and patients.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Wednesday, 13 February 2019.

Interested parties should respond by close of business Sunday, 31 March 2019.

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.

How to submit

Complete the online consultation submission form to upload your submission in either pdf or word format (preferred method).

Consultation submission form

Or submit by email at: devicereforms@tga.gov.au. Your submission must be accompanied by a submission cover sheet.

How to access a Word document

Enquiries

Any questions relating to submissions should be emailed to devicereforms@tga.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.