Jun 1, 2022

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform suppliers and providers when and how their software may be considered a medical device for regulatory purposes.

If you are a maker or distributor of any digital mental health tool, including apps that provide therapy or suicide prevention, internet-based counseling or symptom checkers, you will want to review these requirements to determine if and how you need to comply with TGA regulations.

How do I know if my software qualifies as a medical device?

There are several criteria for determining whether the software you manufacture qualifies as a medical device and thus is subject to Australia’s medical device regulations.

Your software is a medical device if it’s used to:

  • Diagnose, prevent, monitor, predict, make a prognosis or treat a disease, illness or injury
  • Alleviate or compensate for an injury or disability
  • Investigate the anatomy or a physiological process
  • Control or support conception

How are software-based medical devices regulated?

If your app, website, program, internet-based service or package meets the definition of a medical device, it is referred to as a software-based medical device or Software as a Medical Device (SaMD).

If you produce software-based medical devices or SaMDs, you must comply with TGA regulations and list your device with the Australian Register of Therapeutic Goods (ARTG), unless your product is specifically excluded.

New regulations for software-based medical devices went into effect February 25, 2021 and there is a transition period for those already listed on the ARTG.

What do I need to do to determine if my digital mental health software is regulated?

You need to determine if your digital mental health tool qualifies as a medical device. If it doesn’t meet the criteria for a medical device, the TGA does not regulate it.

Under the new regulations that took effect in February 2021, digital mental health tools are excluded from regulation if they are intended for mental health management and meet certain criteria.

To qualify for regulatory exclusion, your mental health tool must:

  • Contain software that follows established clinical practice guidelines
  • Include guidelines that are referenced and visible within the tool
  • Prominently display guidelines to users

If your mental health software is a medical device and does not meet all exclusion criteria, it is regulated by the TGA.

Emergo by UL will provide additional updates from the TGA as they become available.

Learn more about medical device regulations and compliance in Australia from Emergo by UL:


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    Kathryn Burke