top of page

Regulation & Re-classification of Software based Medical Devices - TGA Australia

Writer's picture: Sharan MuruganSharan Murugan

Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software that relies on particular hardware to function as intended, and are regulated in Australia by the Therapeutic Goods Administration (TGA). Software (including mobile apps) is a medical device if it fits the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989.



This guidance is intended to provide information on the regulation that applies to software and apps which meet the legislated definition of a medical device in Australia.


The purpose of this guidance’s is to help manufacturers and sponsors understand how the TGA interprets requirements, and thus indicate how manufacturers and sponsors can comply.


The documents are currently in draft and updates and clarifications will be included as required.


All new applications for the inclusion of software-based medical devices in the Australian Register of Therapeutic Goods (ARTG) must meet these new classification rules.

The Re-classification of software-based medical devices guidances provides information about the new classification rules for software-based medical devices that (PDF):

  • provide a diagnosis or screen for a disease or condition

  • monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition

  • specify or recommend a treatment or intervention

  • provide therapy through the provision of information

The transition arrangements for devices that may need to be reclassified end on 25 August 2021.


Watch this video on how to access the transition period for software-based medical devices.

Comments


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page