Face mask regulation
Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of disease between people, or are intended to be used in a healthcare environment, are medical devices and are regulated by the TGA under the Therapeutic Goods Act 1989.
Unless exempt, medical devices must be included in the ARTG before being imported into or supplied in Australia, or exported from Australia.
Face masks that are regulated by the TGA
Face masks meet 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 suitable for therapeutic use such as for surgical, clinical, medical use, or use in other health services…