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If you're planning to bring a system or procedure pack to market in Australia, this is your starting point.
You need to understand how we regulate these products and your obligations at each stage.
This includes confirming eligibility, selecting the correct classification and meeting conformity assessment requirements.
Being well prepared helps ensure your product meets Australian requirements and avoids regulatory delays.
Start by learning your responsibilities and planning.
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.