You are responsible for effective supply and distribution processes to keep devices safe and available.
You need to manage risks across the supply chain and comply with Australian regulations, including for import and export.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to personalised 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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PageInformation for sponsors conducting market actions for therapeutic goods in Australia.
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PageStep-by-step process for manufacturers to supply devices in, or export them from, Australia.
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PageA step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia.
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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PageLearn how medical devices are regulated in Australia, including ARTG requirements, importing and supply rules for health professionals, sponsor responsibilities, exemptions, and penalties for non‑compliance.
Product types