Manufacture a medical device
Regulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs).
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.
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)
- PageMedical devices must comply with the Essential Principles, which set out fundamental safety and performance requirements.
Medical device reforms
Follow the link below for information about recent and upcoming regulatory changes..
- Australian regulatory guidelines for medical devices (ARGMD)
- Manufacturing medical devices: where to start
- Manufacturing medical devices & 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
- Clinical evidence guidelines: Medical devices
- Clinical evidence guidelines documents for medical devices
Patient implant cards and information leaflets
- Patient implant cards and consumer device 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: Frequently asked questions
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
- Legal supply of COVID-19 test kits
- Ventilator for COVID-19 use in Australia
- Manufacturing medical devices for COVID-19 including 3-D printing
- 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