Consultation: Proposed regulatory changes related to personalised and 3D printed medical devices

9 November 2017

This consultation closes on 22 December 2017.

Invitation to comment

The TGA is seeking comments from interested parties on future options for the regulation of personalised and 3D printed medical devices.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Thursday, 9 November 2017.

Interested parties should respond by close of business Friday, 22 December 2017.

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

About the consultation

The Therapeutic Goods Administration (TGA) is seeking comments on its proposed options to:

  • potentially re-define 'custom-made devices';
  • introduce new definitions within the personalised medical devices vocabulary;
  • clarify entities who may be liable as a manufacturer of a supplied device;
  • harmonise regulatory approaches with other jurisdictions; and
  • include special provisions for certain dental and other low risk devices to reduce unnecessary regulation burden.

The purpose of this consultation is to provide an opportunity for the public to contribute to the development of a regulatory framework for personalised medical devices such as those enabled by 3D printing. Reforms will affect industry, healthcare professionals and patients of these medical devices. Comments will assist the TGA to identify issues and ensure regulation of the devices is appropriate to the level of risk.

Background

The increasing use of 3D printing for medical applications is raising questions globally about the adequacy of the current medical device regulatory frameworks to mitigate risks to patients, and to meet requirements for health care providers and manufacturers. On 10 August 2017, TGA hosted a workshop to consider the adequacy of the current medical devices regulatory framework for custom-made devices, especially high risk (permanently implantable) devices, enabled by 3D printing. The workshop was well-attended by academics, medical specialists (orthopaedic, neurologists, dentists, periodontists, hospital biomedical engineers, surgeons), consumer advocates, medical devices suppliers, custom-made medical device makers, commercial 3D printing organisations, CSIRO and MTP connect representatives, reflecting the high level of interest in the topic.

Content of submissions

TGA's consultation paper poses a number of questions for stakeholders to consider. Submissions may address any, or all, of these questions directly, or address any issues that may arise out of the proposed regulatory changes.

How to submit

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Business Improvement and Support Section
Medical Devices and Product Quality Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be directed to the Director, Business Improvement and Support Section by email 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. Once finalised, the regulatory changes and implementation arrangements will be published on the TGA website.

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.