Developing and supplying 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.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
Import and export
Access requirements for import and export of therapeutic goods.
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PageTo export medical devices, including in-vitro diagnostic medical devices (IVDs) and other therapeutic goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.
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PageInformation for health professionals importing and supplying medical devices.