The Therapeutic Goods Administration (TGA) publishes information and resources about face masks for consumers, health professionals and industry. This page compiles all of our resources related to face masks and COVID-19.
For other COVID-19 information from the TGA, see Coronavirus (COVID-19): Information on medicines and medical devices.
A face mask meets the definition of a medical device when the following claims are made:
- the face mask is to be used for the prevention of the transmission of disease between people, or
- the face mask is intended for therapeutic use such as for surgical, clinical, medical use, or use in other health services.
If the manufacturer’s labelling, advertising, or documentation contain the claims above, the face mask is considered to be a medical device and is required to be included in the Australian Register of Therapeutic Goods (ARTG).
The following resources provide an overview of the regulatory requirements for face masks in Australia: