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Australia TGA: Regulation of Software based Medical Devices

On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices" that helps manufacturers and sponsors understand how the TGA interprets requirements, and thus indicates how manufacturers and sponsors can comply.

Software-based medical devices are medical devices that incorporate software 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 us.

Software (including mobile apps) is a medical device if it fits within the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989- external site unless otherwise excluded.

Software-based medical devices rely on software for their intended use, diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TGA classifies software-based medical devices based on their intended purpose and risk, ranging from Class I (low risk) to Class III (high risk).

There are multiple guidances linked with this guidance and It is the responsibility of each manufacturer or sponsor to understand and comply with these requirements. It is recommended that manufacturers and sponsors familiarize themselves with the legislative and regulatory requirements in Australia, and seek professional advice if necessary.

One of the important sections covered in this guidance is the Regulation of Digital Therapeutics (DTx). Digital Therapeutics (DTx) is a subset of software as a medical device (SaMD) and intended to treat or alleviate a disease, disorder, condition, or injury. It works by generating and delivering a medical intervention that has a demonstrated positive impact on a patient’s health.

The purpose of this guidance and its related guidances is to offer insights into the regulatory requirements in Australia for software and applications that meet the defined criteria of a medical device.

For more exclusive details, click this LINK.

Also, check out this updated guidance on "Boundary and combination products" that help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.


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