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If you're planning to supply a software medical device in Australia, including those using artificial intelligence, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage.
This includes:
determining if your product meets the medical device definition
determining if an exclusion or exemption applies
selecting the correct classification
compiling evidence of safety and performance.
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning your responsibilities and the regulatory requirements that apply to your device.
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.