Overview
Software, including mobile applications, is classified as a medical device under section 41BD of the Therapeutic Goods Act 1989, unless an exception applies. The term "software-based medical device" refers to software that fits the definition of a medical device in one of two circumstances: it is either integrated or depends on specific hardware to operate as intended, or it is a standalone piece of software, also referred to as a medical device (SaMD). In Australia, the Therapeutic Goods Administration (TGA) is responsible for regulating both.
Classification Rules
The guidance provided by the TGA includes classification rules, enabling manufacturers to determine how their software-based active medical devices will be classified.
Changes to Legislation
The TGA has made changes to legislation governing software-based medical devices, including software that serves as a medical device in its own right. The regulation of software-based medical devices includes software as a medical device (SaMD). This review took effect on February 25, 2021, and is summarized in guidance that outlines the devices requiring reclassification and the transition options available.
Cybersecurity Guidance
Due to the seriousness of cybersecurity issues related to software, cybersecurity guidance is now necessary for medical devices and health professionals.
Regulatory Updates
Considering data collection components utilized by Software as a Medical Device (SaMD) integrated into smart devices, tablets, laptops, and similar digital hardware, the regulatory updates released by the TGA are outlined as follows:
- The smart devices, which are end consumer products (e.g., smartphones, tablets, and laptops) where the data collection component is integrated, such as sensors, are not required to be included in the Australian Register of Therapeutic Goods (ARTG).
- The SaMD must be validated against the data collection component(s) and/or smart device to demonstrate compliance with the essential principles for the intended use of the SaMD, ensuring it is safe and meets its intended purpose.
- The level of scrutiny applied to the data collection component(s) will reflect the level of risk associated with the intended use. Here is an example provided by the TGA:
- Given a Class III SaMD intended for the diagnosis of a life-threatening disease or condition, a high level of scrutiny is expected. This includes fulfilling the validation of any sensors used for their intended use, such as a camera.
Conclusion
In conclusion, SaMDs must be included in the ARTG to be supplied in Australia, along with documentation of validation against the data collection component(s) using the appropriate testing. However, the data collection component(s) itself is not necessary to be included in the ARTG if it is integrated into a smart device for the end consumer.
Resources
The TGA has provided guidelines and FAQs to assist developers and users of software to be supplied for use in Australia for health or medical care. For further information regarding the regulation of software-based medical devices, please see the guidance on the topic published on the TGA website.
Regulatory link reference - https://www.tga.gov.au/regulation-software-based-medical-devices