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Consultation: Scope of Regulated Software based products

Related information

25 March 2020

This consultation closed 13 May 2020.

Invitation to comment

Advances in computing technology has given rise to a rapidly evolving environment that includes many new medical device software products, and many health-based products which are crossing and/or blending traditional boundaries of therapeutic product definitions. As a consequence, the boundary for regulated software products is becoming more difficult to identify, a situation that has caused therapeutic goods regulators around the world to consider, or to implement, changes to their frameworks to address uncertainty.

The TGA sought feedback from stakeholders on proposed measures to clarify the boundary for software-based products that are captured under the regulatory framework for medical devices in Australia. The measures also seek to ensure that sponsors and manufacturers of software-based products are not subject to unnecessary regulatory oversight. We are specifically seeking views on what type of software-based products could potentially be carved-out from regulation by the TGA.

Feedback received from the previous consultation on Regulation of software, including Software as a Medical Device (SaMD) that closed on 31 March 2019, indicated that there was confusion over what was considered a medical device. Consequently, it was considered important to clarify this in consultation with stakeholders prior to the commencement of the regulatory changes.

Consultation documents

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Document released for consultation on Wednesday, 25 March 2020.

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 proposal, including suggestions for alternatives.
  • An assessment of how the proposal will impact on you.


Any questions relating to submissions should be directed to the Regulatory Pricing and Decision Review Section by email

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. Feedback from interested parties will be considered before seeking government’s approval of the 2020-21 fees and charges. A stakeholder feedback summary will be included in the TGA’s cost recovery implementation statement.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if we would like to seek clarification of any issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available; and
    • 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.