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Guide: Navigating major regulation changes in digital health

The Therapeutic Goods Administration (TGA) has announced major changes to how software-based medical devices are regulated - we've summarised the latest information about these important changes!

The rapid advancement of COVID-19 in 2020 ushered in an unprecedented uptake of digital technology in 2020, in the healthcare sector.

In 2021, this trend is showing no signs of slowing down. 

To that end, it's not surprising that the Therapeutic Goods Administration (TGA) has announced major changes to how software-based medical devices will be regulated.

How medical device regulation works

In Australia, software has the potential to be regulated by the Therapeutic Goods Administration (TGA) as a medical device if it falls within the definition of “medical device".

Medical devices are those that are used for any of the following purposes:

  • the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
  • the diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
  • the investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
  • the control or support of conception.

In short, the TGA is aiming to clarify how and what is classed as a medical device, in two main ways:

  1. introducing 'exclusions' or 'exemptions' of certain software-based medical devices from the entire scope of the Therapeutic Goods Act
  2. introducing new rules that change what classification level a device is assigned

Change 1: Exemptions and Exclusions

The major change to be introduced is the ‘exclusion’ or ‘exemption’ of certain software-based medical devices from the scope of the Therapeutic Goods Act. 

It is believed that the impetus behind this change is to help align Australia’s regulatory framework for software-based medical devices with other international regulatory regimes. 

The ultimate outcome here is that, for suppliers of technology that poses no significant risk to safety, there will be a heavily reduced regulatory burden.

At a high level, excluded devices include:

  • Consumer health products
  • Enabling technology
  • Digitisation technology
  • Population based analytics
  • Laboratory information management systems

Exemptions are for devices not intended to replace clinical judgement and exist only to support and enhance clinical recommendations.

Change 2: Reclassification

The second major amendment to the Therapeutic Goods Act is the introduction of new classification rules for software-based medical devices.

This change not only affects all future applications for entry onto the Australian Register of Therapeutic Goods (ARTG), but also impacts devices already entered on the ARTG.

Medical devices are classified into ‘classes’, with the categorisation dependent on the risk they pose to the health and safety of users interacting with the device.

The changes are aimed at modernising the classifications and it's therefore possible, they may result in an already registered device being moved into a higher or lower risk class.

The upshot for software-based medical devices?

These changes will affect any device currently on the ARTG and any that intend to be registered in the future.

Given their significance, you might need to consider:

  • is my software eligible for exemption or exclusion?
  • is my software going to move risk class?

If you’re having trouble understanding how (or if) they affect you, get in touch with the Curve team today to find out more.

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