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Developing software based medical devices, including those using artificial intelligence (AI), requires quality controls.
If you develop the software, you are the manufacturer. A manufacturer must meet safety, quality, and performance requirements. You may also need to put in place a Quality Management System.
If your software is hosted or distributed across borders, it may be considered imported or exported under Australian law. For example, supply through cloud platforms or app stores. In this case, you'll have to meet our requirements for international supply.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.