Producing and supplying medical devices requires meeting regulatory requirements to ensure quality, safety and performance.
Some devices must be manufactured under a certified Quality Management System. They must also comply with the Essential Principles to ensure safety and performance.
Effective supply and distribution processes help keep devices available and safe for users. If you import or export medical devices, you must comply with Australian regulations.
Understanding these rules helps you meet your legal obligations and manage risks throughout the supply chain for medical devices in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information about medical devices, and specific types of medical devices. You may also have to meet obligations that apply to all products.
Supply
Understand your obligations to manage the ongoing supply of products.
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PageWe are managing the impact of the European Union Medical Devices Regulation (EU MDR) transition in Australia.
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PageLearn which changes to a device are considered a UDI Trigger, and how to manage these changes.
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PageHow to supply a therapeutic good and get started. Find out how to confirm your product is a therapeutic good, how it's regulated and if it needs to be entered in the Australian Register of Therapeutic Goods (ARTG).
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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.
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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.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.
Import and export
Access requirements for import and export of therapeutic goods.
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PageApprovals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions.
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FormsInformation and links to the application to import or export a therapeutic good that is mercury form.
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GuidanceThis guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).
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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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PageAustralia has rules on importing medicines and medical devices.
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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.
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PageThe TGA is introducing a streamlined Consent to Supply process for Unique Device Identification related Essential Principles.