You are here

Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems

6 March 2019

This consultation closed on 29 April 2019.

Invitation to comment

The Australian Government endorsed a significant program of reform to further strengthen the regulation of medicines and medical devices in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates these products, and is responsible for implementing the Government's reforms.

Medical devices are regulated in Australia having regard to the risks (to the individual or public health) considered in the context of the device's intended use. The TGA periodically reviews classification rules for medical devices to ensure they continue to be appropriate. When undertaking such reviews, the TGA has regard among other things, to the international best regulatory practice and any emerging issues.

The EU Regulation on medical devices (2017/745) (EU MD Regulation) introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes.

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. While the new classification rules in the EU more appropriately reflect the intended use and the risks of medical devices, this paper considers the extent to which a similar approach will be appropriate in the Australian regulatory context, to further our aim of enhancing the smooth functioning of the medical devices market while also achieving high standards of quality, safety and performance.

Consultation documents

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.


Document released for consultation on Wednesday, 6 March 2019.

Interested parties should respond by close of business Monday, 29 April 2019.

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


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.


Any questions relating to submissions should be emailed to

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.