About in vitro diagnostic devices
In vitro diagnostic (IVDs) devices are medical devices used to help screen and diagnose for diseases, conditions or aliments, contributing to clinical management and monitoring.
Examples of IVDs include:
pregnancy tests
COVID rapid antigen tests
pathology tests that check a person’s iron levels.
IVDs may be used by health professionals in laboratories or at the point of care. Some are approved for self-testing, allowing the general public to use them.
We assess IVDs for safety and performance. Unless exempt or excluded, these must be included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. You may also have to meet obligations that apply to all medical devices and all products.
