About personal protective equipment
Personal protective equipment (PPE) are products that help protect people from infection or exposure to harmful substances.
Examples of these include face masks, gloves, gowns and respirators.
If PPE is intended to prevent disease, it’s regulated by us as a medical device.
To be legally supplied in Australia, PPE that is a medical device, must be included in the Australian Register of Therapeutic Goods (ARTG).
From 1 July 2026, medical devices are required to have a UDI (Unique Device Identification). Starting with higher risk (class IIb and III) devices, UDI will help us -consumers, health professionals, industry and other stakeholders – easily access device information.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
