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Post-market review of face masks: Overview

18 August 2021

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page introduces the review and provides guidance for suppliers and users of face masks. For outcomes of the review see:

For a collection of face mask related web resources see the Face masks and COVID-19 page.

On this page: Background to the review | If you supply face masks | If you use face masks | Reporting concerns

Background to the review

COVID-19 has increased the demand and supply of personal protective equipment (PPE) such as face masks and respirators, gloves, face shields, goggles, and gowns designed to protect the wearer from the spread of disease, illness and infection.

Some of these products meet the definition of a medical device and so must be included in the ARTG before being supplied. Some products do not meet the definition of a medical device and, while they may still be used to prevent the spread of diseases including COVID-19, they do not need to be included in the ARTG.

For more information about the use and regulation of PPE, including face masks and respirators, please review:

Due to a rapid increase in demand for the manufacturing, importation and sale of face masks, there has been an increase in medical device inclusions in the ARTG, with many manufactured and imported from overseas.

Concerns have been raised about the quality and effectiveness of some products, particularly face masks, including that they:

The TGA post-market review of face masks will validate if the devices included in the ARTG through the Class I inclusion process meet all the regulatory requirements and perform as intended. The masks supplied to the National Medical Stockpile and State and Territory Health Departments are prioritised in our post-market review.

On 22 March 2020, the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 was made to support the purchase of certain kinds of medical devices by the Australian Government Department of Health for the National Medical Stockpile. The emergency exemption supported the Australian Government's rapid COVID-19 response by facilitating access to certain kinds of medical devices intended to assist in reducing the transmission of infection between individuals, particularly patients and health care professionals. The exemption ceased on 31 January 2021.

During high-risk activities, the use of a face-shield in addition to respiratory protection will provide additional protection against fluid and droplets which is part of current clinical guidance.

Note

The TGA is aware of recently identified issues with some filtering face piece respirators that claim compliance as KN95 respirators against the Chinese national standard for Respiratory Protection, GB 2626.

There are concerns these devices may not provide consistent and adequate respiratory protection based on testing conducted by National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC). These concerns do not relate to the GB 2626 standard, but to the manufacture of some masks. A comparison guide of some respirators standards can be found at: Comparison of P2, FFP2, KN95, and N95 and Other Filtering Facepiece Respirator Classes (pdf,191kb).

Health Canada and the US Food and Drug Administration (FDA) have issued safety notices for certain face masks, and the TGA will consider these notices in our post-market review.

If you supply face masks

If you are the legal entity responsible for importing and supplying face masks (i.e.: the sponsor), you must ensure all regulatory requirements relating to your products are met. If you are considering supplying a medical face mask, you should refer to our guidance on the Evidence requirements for face masks that are medical devices. You should also ensure the manufacturer is aware of the kind of evidence required to demonstrate key performance aspects. You should also:

  • Determine if your product meets the definition of a medical device. If your product does meet the definition of a medical device, you should ensure it is included in the ARTG before you import and/or supply it. Further information is available on the TGA website.
  • Ensure you have the following evidence available to provide to the TGA when requested as part of the post-market review:
    • declaration of conformity from the manufacturer (conformity assessment certificate);
    • a list of models of masks, supply numbers by model and year (if applicable), and the states within Australia where you have distributed the face masks;
    • details of the manufacturing standards (if applicable, the international or Australian standards) the devices conform to and evidence of compliance to those standards (certification by an accredited certification body and/or test reports demonstrating compliance to particular components of the standard will be required, dependent upon the claims made by the manufacturer);
    • a copy of all packaging and labelling. If the labelling makes reference or claims conformity to one or more standard, you must ensure the manufacturer holds evidence, by way of certification, to demonstrate conformity with the standard, and that the labelling and advertising claims comply with Australian regulatory requirements and any labelling requirements of the standard;
    • 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 COVID-19, 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).

Note

If you are the supplier of a medical device in Australia, it is your responsibility to ensure all regulatory requirements are met. Refer to our guidance on the Evidence requirements for face masks that are medical devices.

If the labelling on the device that you supply indicates that it is certified to, or complies with all aspects of a particular standard, be that by use of common labelling terms such as P2, KN95, FFP2, or N95, or with the name of the standard, such as AS/NZ 1716:2012 or ISO 13485, the manufacturer must hold evidence to support those claims. Refer to our guidance on medical/surgical face masks and respirator standards - key performance aspects.

There are civil and criminal penalties associated with supplying a medical device that is not included in the ARTG or subject to an exemption, for providing false or misleading information to the TGA, and for misleading advertising.

If you are supplying a device that does not meet the regulatory requirements, the TGA strongly recommends that you contact the TGA, or cease supply and cancel your ARTG inclusion.

Note

The manufacturer is responsible for determining the intended purpose of your medical device. The intended purpose of the medical device can be ascertained from the manufacturer's instructions for use, advertising material, technical documentation, and/or product label(s).

If you change the intended purpose of the medical device, you will meet the legislative definition of a manufacturer and you will need to meet the manufacturer's obligations under the relevant legislation.

The TGA has recently become aware of instances where the Australian sponsor of a medical device included in the ARTG, has supplied and/or advertised the medical devices with a different intended purpose than originally specified by the manufacturer.

An example of changing the intended purpose is when a sponsor or distributor conducts additional testing to support the use of the device in a different setting, such as claiming fluid resistance for a non-surgical face mask that would now be intended for use in a surgical/medical setting.

If a sponsor or distributor changes the intended purpose of a medical device, this creates additional risks to the user, as the manufacturer will not have accounted for these risks in the design and construction of their products.

Changing or extending the manufacturer's intended purpose without consent by the manufacturer is considered a breach of the Therapeutic Goods Act 1989 and penalties may apply.

If you use face masks

Only personal protective equipment (PPE) for therapeutic use are required to be in the ARTG. For example, surgical or examination masks intended to reduce or prevent the transmission of disease or micro-organisms (such as bacteria or viruses) are medical devices. These products are regulated by the TGA and are required to be included in the ARTG before they can be supplied.

A PPE Buyer's Guide is available from the business.gov.au website.

If you are a consumer of these products, you should familiarise yourself with the differences in available face masks and be aware of the manner in which these products are used in order to maximise the protection they can offer. In particular:

  • While other languages can also be used, medical devices must be supplied with the labels, packaging and Instructions for Use in English.
  • The name and address of the supplier, and the name of the manufacturer, should be provided on the packaging or label.
  • You can check if a face mask is included in the ARTG by searching the ARTG using the name of the person or company legally responsible for the product (ie: the sponsor). Product names are not available in the ARTG.
  • Face masks are supplied as both medical devices and as personal protection for use in industrial settings. Ratings such as N95 and P2 relate to standards that may not be associated with a therapeutic use. You should familiarise yourself with the specific claims and ratings associated with the product you are using to ensure it is appropriate for the manner in which you intend to use it. Standards Australia has published a Summary of information on standards and conformance for PPE products that outlines the factors assessed under each standard.
  • Ensure you always use your medical device in the manner intended by the manufacturer by following the Instructions for Use.
  • Be aware of potentially counterfeit devices. Look at product markings, such as the name of the manufacturer, to determine whether anything is amiss (incorrect spelling, faded packaging, incorrect filters/materials, etc.).

Note

If you believe your mask is fraudulent or makes therapeutic claims and is not included in the ARTG, you should stop using it.

Importance of a proper fit

For a respirator to provide its designed protection, it is essential that an adequate face seal is achieved between the facepiece of the respirator and the face of the wearer.

End users should check facial fit to ensure the right respirator products have been issued and that they are wearing the respirators properly. This is achieved through Fit Testing and Fit Checking. More details about respirator fit tests and checks can be found in:

Note

During high-risk activities, the use of a face-shield in addition to respiratory protection will provide additional protection against fluid and droplets, which is part of current clinical guidance.

Reporting concerns

The TGA has online forms for reporting any concerns or issues:

For frequently asked questions and more information about reporting medical device adverse events, see Medical device incident reporting & investigation scheme (IRIS).

For more information about face masks visit Face masks and COVID-19.