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Consultation: Review of the regulation of certain self-testing IVDs in Australia

21 November 2019

This consultation closed on 6 December 2019.

The TGA is sought comments from interested parties, including clinicians, patients, consumer groups and industry, as to whether the Therapeutic Goods (Excluded Purposes) Specification 2010 continues to serve a useful and necessary purpose in prohibiting supply of certain self-testing IVDs for serious diseases. The consultation paper outlines the background to the Excluded Purposes Specification and which self-testing IVDs are currently prohibited from supply.

The feedback received in response to the consultation will inform a recommendation to the Minister on whether to remake the Excluded Purposes Specification after it automatically expires (sunsets) in October 2020.

Consultation documents

How to access a pdf or Word document


Document released for consultation on Friday, 27 September 2019.

Interested parties should respond by close of business Friday, 6 December 2019.

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

About the consultation

All interested parties are invited to comment on the matters raised in the consultation paper by making written submissions as outlined below. The feedback received will inform a recommendation to the Minister on whether to remake the Excluded Purposes Specification after it automatically expires (sunsets) in October 2020.


The Excluded Purposes Specification came into force on 1 July 2010 following consultation with a range of stakeholders who expressed concerns about the availability of home-use (self-testing) IVDs for serious diseases. Under the Legislation Act 2003 all legislative instruments 'sunset' or cease automatically after ten years unless action is taken to remake the instrument (or it is otherwise exempt from the requirement to sunset). The TGA has been advised that the Excluded Purposes Specification will sunset on 1 October 2020 unless it is remade.

Content of submissions

Submissions may address any, or all, of the questions posed in the consultation document or other identified issues.


Any questions relating to submissions should be directed to the IVD Reforms Team, Medical Devices Branch, by email 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.

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.