The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices.
The flowcharts in the guidance document show which software products are regulated as a medical device and which are not.
In Australia, software and apps that meet the definition of a medical device are regulated by the TGA. Recent reforms have been implemented to clarify the requirements of regulated software based medical devices, including introducing a number of exclusions and exemptions for specific types of software products.
What are excluded products?
Excluded products are not medical devices, and are not subject to any TGA regulatory requirements.
Is exempt software a medical device?
Exempt software is a medical device but is not subject to all regulatory requirements.
Guidance on clinical decision software
Upcoming guidance on Clinical Decision Support Software will provide detailed guidance on the exemption, including which products are covered, and which requirements still apply.
Source: TGA Australia