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
To help confirm you have a medical device use our online tool: Is my product a medical device?
For information on market authorisation and the ARTG inclusion process for medical devices, including IVDs go to Supply a medical device.
Sponsors of medical devices with medicinal substances can find more information on the Medicinal substances in medical devices webpage.
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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GuidanceGuidance 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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SectionInformation and guidance on the regulation and manufacture of specific types of medical devices.
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PageInformation and guidance about the regulation of point-of-care manufacturing of medical devices.
Medical device reforms
Follow the link below for information about recent and upcoming regulatory changes..
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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.
More information
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
- Manufacturing medical devices: where to start
- Manufacturing medical devices and IVDs
- Essential Principles checklist (medical devices)
Labelling and instructions for use
- Medical device labelling obligations
- The Poisons Standard and medical devices
- Electronic Instructions for Use - eIFU
Clinical evidence guidelines
Patient implant cards and information leaflets
- Best practice for Patient Information Leaflets and Patient Implant Cards
- Medical device patient information leaflets and implant cards
Consumers, patients and health professionals
- Medical devices
- Breast implant hub
- Urogynaecological (transvaginal) surgical mesh hub
- Cosmetic injections
- Unique Device Identification (UDI) system
- Off-label use of medical devices
Sponsors and manufacturers
- Supply a medical device
- Medical device inclusion process
- Guidelines for sterility testing of therapeutic goods
- Export of medical devices
- Medical device cyber security guidance for industry
Priority review pathway
COVID-19
- Legal supply of COVID-19 test kits
- Ventilator for COVID-19 use in Australia
- Ventilators permitted for supply under COVID-19 Emergency Exemption
- Advertising COVID-19 rapid antigen tests
- Advertising COVID-19 rapid antigen point-of-care tests and self-tests (home use tests)
- COVID-19 rapid antigen tests - information for manufacturers and sponsors
- Instructions for sponsors who have interest in supplying a COVID-19 self-test
- Test to verify the analytical sensitivity of COVID-19 Rapid Antigen Test Kits
Action Plan for Medical Devices
This webpage on the TGA website was printed on 14 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device