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To legally supply a system or procedure pack, it must be included in the Australian Register of Therapeutic Goods (ARTG). We regulate these packs as a single medical device.
You can apply for ARTG entry through our Business Services portal. We assess your pack for safety, performance and quality. Fees apply for application, evaluation and annual registration.
This stage ensures your pack complies with regulatory requirements and is authorised for supply in Australia.
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.