Australia – Face masks and respirators that are regulated by the TGA

The Therapeutic Goods Administration (TGA) has received a number of questions about the regulation of face masks during the COVID-19 pandemic. This page provides consumers, health professionals, and state and territory government officials with guidance to help determine when a face mask is a medical device and therefore must be included in the Australian Register of Therapeutic Goods (ARTG).

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…