Medical devices imported into, supplied in, or exported from Australia must be included in the Australian Register of Therapeutic Goods (ARTG). This needs to be done by the device's Australian sponsor.
Medical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
Content from the Australian Regulatory Guidelines for Medical Devices (ARGMD) has been broken up and included as individual pages and documents on our new website.
Key information
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Decision treeUse this decision tool to help you determine if your product is a medical device.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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PageA medicinal substance in a medical device must meet Australian manufacturing and quality control requirements.
Steps to supply (manufacturer)
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PageStep-by-step process for manufacturers to supply devices in, or export them from, Australia.
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PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
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PageUnderstand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).
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PageGuidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities.
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PageWork is ongoing to review medical device regulations for point-of-care (POC) manufacturing.
Medical device reforms
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PageThe medical devices reforms aim to enhance the safety, performance, and quality of medical devices in Australia and focus on patient safety.
Guidance documents
Labelling and instructions for use
- Labelling medical devices to meet regulatory requirements
- Supplying or manufacturing medical devices containing poisons
- Supplying electronic instructions for use (eIFU) for medical devices
Clinical evidence guidelines
- Clinical evidence guidelines for medical devices
- Clinical evidence guidelines documents for medical devices
Patient implant cards and information leaflets
Sponsors and manufacturers
Related links
Product types
Topics