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Consultation: Regulation of software, including Software as a Medical Device (SaMD)

13 February 2019

This consultation closed on 31 March 2019.

Invitation to comment

The Therapeutic Goods Administration (TGA) sought feedback on how software, including Software as a Medical Device, is regulated in Australia. Software is regulated by the TGA under the existing medical device framework; however, advances in technology, including the emergence of 'apps', are not adequately covered in the current scheme.

This consultation focuses on proposed regulatory reforms for medical device software, including software that functions as a medical device in its own right (SaMD), and the impact of these reforms. The proposed changes set out in this consultation seek to better regulate software, including SaMD, and will wherever possible be harmonised with international best practice.

Consultation documents

How to access a pdf or Word document


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').


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.