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Face masks and COVID-19

11 February 2021

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.

Overview

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).

Face masks that are medical devices, and are non-sterile, are regulated as Class I medical devices, which is the classification for low risk devices. However, the TGA has put in place more rigour and validation process for face masks included in the ARTG, including an audit of the evidence held by the manufacturer to demonstrate the performance and the quality of the face masks. Further information can be found here:

The following resources provide an overview of the regulatory requirements for face masks in Australia:

Safety alerts for face masks

The TGA has issued the following safety alerts related to face masks:

For all safety alerts issued by the TGA see Safety information.

Post-market review of face masks

The TGA is undertaking a post-market review of face masks included in the ARTG. For information related to this review, see:

Importing, supplying, or manufacturing face masks

The following resources are intended to help importers, suppliers, and manufacturers of face masks to understand their regulatory obligations:

Using face masks in healthcare settings

The following resources provide guidance to healthcare professionals on the use of face masks:

Consumer information

The following resource provides guidance to consumers on the different types and use of face masks: