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Australia's TGA: Guidance on Regulation of Software based Medical Devices

Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based Medical Devices".

"Software based medical devices are medical devices that incorporate software or are software".


These devices either include software or are entirely software-based, such as software as a medical device. They may also rely on specific hardware to fulfill their intended purpose.


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.


This guidance aims to assist manufacturers and sponsors in comprehending the TGA's interpretation of requirements and provides guidance on how they can ensure compliance with those requirements. This is a general guide, and it is the sole responsibility of each manufacturer or sponsor to thoroughly understand and adhere to these requirements.


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.


Click this LINK to know more about topics such as Software as a Medical Device (SaMD) – use of data collection components, Artificial Intelligence Chat, Text, and Language, etc.

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