TGA carves out exemptions for some software-based medical devices

Australia’s Therapeutic Goods Administration (TGA) has published the Therapeutic Goods (Excluded Goods) Amendment (Software-Based Products) Determination 2021, which will become effective on February 25, 2021. This amends the Therapeutic Goods (Excluded Goods) Determination 2018 to identify software-based devices, including software as a medical device (SaMD), that are excluded from the TGA's medical device regulatory framework and should not be included in the Australian Register of Therapeutic Goods (ARTG). There are 15 software types identified here as excluded goods.

Categories of software-based devices exempted from TGA regulation

The software categories “carved out” from TGA regulation include the following:

• Consumer health products for preventing or managing conditions, monitoring vital signs, providing health and wellness coaching, and collecting patient-reported outcome measures (PROMs)
• Digital mental health tools, including cognitive behavior therapy tools
• Products designed to enable communications, management of health processes or facilities, clinical workflow management, or notification of health professionals
• Software used solely to store or transmit patient images
• Middleware used to connect applications within a healthcare system
• Software designed to make calculations using clinical data
• Electronic health records and data analytics software
• Laboratory information management systems

Many of the software-based product descriptions include additional criteria that must be met if the products are to qualify for exemption from regulation, such as the requirement that the software is not intended to provide diagnosis, screening, treatment recommendations, etc.

Guidance documents accompany regulatory changes for software-based medical devices

To accompany the regulatory changes, the TGA has released the following four new draft guidance documents, which are accessible from the “Regulation of software based medical devices” guidance page:

• Is my software regulated? – includes flowcharts illustrating which software and apps are regulated as medical devices
• How the TGA regulates software based medical devices – summarizes the TGA’s regulatory approach for software-based medical devices
• Regulatory changes for software based medical devices – summarizes changes to the regulation of software-based devices, including software as a medical device (SaMD), and outlines transitional arrangements for devices that may be reclassified, exempted, or excluded
• Examples of regulated and unregulated software (excluded) software based medical devices – provides examples that help illustrate the boundary between regulated and unregulated software

These guidance documents are currently in draft form, and the TGA provides an email address to which feedback on any of them can be directed. Also available on the general guidance page are links to International Medical Device Regulators Forum (IMDRF) technical documents on SaMD and a literature review exploring the risks of harm from medical software.

Upcoming exemption and online classification tool

Emergo by UL has also learned that the TGA has introduced an exemption for some clinical decision support software (CDSS), and the agency plans to soon publish guidance related to the exemption.

Finally, the TGA is working on an online classification tool that is meant to be released by February 25, 2021.

Related resources on Australian medical device regulation:

• Australia emergency use pathways for medical devices
• Australian TGA medical device registration consulting
• Australian TGA Sponsor in-country representation
• Whitepaper: Medical device registration in Australia and New Zealand