Australia – Evidence requirements for face masks that are medical devices

If you are considering supplying face masks (including respirators) that meet the definition of a medical device in Australia, you will need to apply for the inclusion of these products in the Australian Register of Therapeutic Goods (ARTG).

As the legal entity responsible for importing and supplying face masks (i.e.: you are the sponsor), you must ensure all regulatory requirements relating to the products being supplied are met. All face mask applications for inclusion in the ARTG will be subject to an audit by the TGA and the following information and documents will be requested:

  • The manufacturer’s Declaration of Conformity to the Australian requirements;
  • A copy of the manufacturer’s technical documentation or specifications which state the manufacturer’s intended purpose of the face mask or respirator (this is the manufacturer’s documentation and not a copy of the GMDN term selected with the application for inclusion in the ARTG);
  • Details of the manufacturing standards (if applicable, the international or Australian standards) the devices conform to and evidence of compliance to those standards, which includes:
    • certification by an accredited certification body and/or
    • all test reports demonstrating compliance to particular components of the standard or claims made by the manufacturer.
  • The number of face masks or respirators manufactured in each lot;
  • A copy of all packaging and labelling as supplied to the Australian consumer. You must ensure the above test evidence is provided if the labelling makes reference or claims to:
    • conformity to one or more standards, and/or
    • filtration efficiency, sterility, facial fit, breathability, or fluid resistance.
  • A copy of the Instructions for Use that are supplied with your product (if applicable);
  • Where the intended purpose of the device claims to protect the wearer from specific viral infections or bacteria, such as COVID-19 or tuberculosis, either specifically or by implication, appropriate evidence to support such a claim (for example, evidence from a clinical trial, or testing from an accredited laboratory to a recognised standard) will be required…