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:
- Face masks and respirators that are regulated by the TGA
- Regulation of Personal Protective Equipment and COVID-19
This video provides manufacturers and suppliers technical information on face masks and respirators that are regulated as medical devices.
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:
- Post-market review of face masks: Overview
- Post-market review of face masks: Cancelled ARTG entries
- Post-market review of face masks: Non-compliance notices
- Post-market review of face masks: Outcomes and actions
- Testing results of face masks and respirators: TGA Laboratories testing report
- For information about all other TGA compliance actions related to face masks, see Compliance actions and outcomes, Media releases & statements and Medical devices and IVDs: Cancellations from the ARTG.
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.
- Regulation of Personal Protective Equipment and COVID-19
- Face masks and respirators that are regulated by the TGA
- Guidance on medical/surgical face masks and respirator standards - key performance aspects.
- Evidence requirements for face masks that are medical devices
- Importing personal protective equipment into Australia during the COVID-19 pandemic
- Manufacturing medical devices for COVID-19 including 3-D printing
Using face masks in healthcare settings
The following resources provide guidance to healthcare professionals on the use of face masks.
- Advice on face masks and gowns during COVID-19
- Reuse of face masks and gowns during the COVID-19 pandemic.
Consumer information
The following resource provides guidance to consumers on the different types and use of face masks.