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Face masks and respirators that are regulated by the TGA

19 August 2020

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 (see the Therapeutic Goods (Specified Articles) Instrument 2020). They 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.

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 ARTG.

Promoting a product as "TGA approved", or including other government endorsements, whether it is included in the ARTG or not, is a violation of the Therapeutic Goods Advertising Code.

Though not a requirement, the ARTG number may be included in the labelling or on the packaging.

Face masks that are exempt from TGA regulation

Face masks which are non-sterile and are not intended by their manufacturer to be used for the prevention of the transmission of disease between people, are excluded from regulation by the TGA under the Therapeutic Goods (Excluded Goods) Determination 2018.

Face masks for use in the community

There has been a significant increase in the domestic manufacture of reusable cloth masks and single-use face masks intended to be used by the general public when social distancing is not possible. These types of face masks are not intended for use in a clinical setting or explicitly to prevent the transmission of disease between persons and therefore are not subject to the same regulations as surgical masks or some respirators.

This type of reusable cloth mask or single-use mask can be manufactured and supplied without needing to be included in the ARTG.

However, these masks must not be advertised or labelled in a way that indicates the mask prevents the spread of disease between people, or for the use in healthcare (including aged care) settings. Instead, manufacturers could clearly indicate the mask is designed to be used by the public when social distancing is difficult or for general activity.

What if there is a loose leaf information stating a face mask is 'not for medical use'

In some cases, an individual or organisation may have purchased face masks for therapeutic use (e.g. in a clinical setting) based on their inclusion in the ARTG and subsequently received face masks with loose leaf information stating 'not for medical use'.

In these cases, you should consider the evidence and information about the intended purpose provided by the manufacturer to determine if the mask may be used in a clinical setting.

Be aware that a mask does not need to be suitable for medical use in order for it to be included in the ARTG. For example, the mask may be intended to prevent transmission of disease between persons in a non-clinical setting.

Amendment to Chinese export regulation

The TGA is aware of loose-leaf inclusions in Mandarin of 'not for surgical use' or similar in boxes of face masks.

On 25 April 2020, the Chinese government announced changes to the regulatory arrangements for the export of medical supplies and PPE, including face masks. The revised regulatory arrangements require medical products for export to either be registered with the National Medical Products Administration (NMPA) or be included in the 'white list' of internationally certified suppliers, which verified by local commerce authorities for medical products and/or non-medical PPE. The TGA does not hold information regarding the requirements for inclusion in either of these lists.

The Chinese government decided that PPE products manufactured in China, but not by a manufacturer on either white list or NMPA list, were required to include labelling (often through insertion of loose leaf strips, in a Chinese language, into the product) as non-medical products.

Labelling or other information accompanying a face mask which identifies the mask as 'not for medical use' does not preclude it from being a 'medical device'. This type of information does not indicate the mask does not meet the TGA's required quality and performance standards.

Interpreting labelling claims

The manufacturer's intended purpose is a key consideration when deciding if a face mask is a medical device. A face mask may still be a medical device even if it is labelled as 'not for medical use' as the manufacturer may intend it to be used for the prevention of the transmission of disease between people but in a surgical setting.

The table below provides examples of labelling and claims, including information provided by the manufacturer, and how we interpret them to determine if face masks should be included in the ARTG.

Examples of labelling claims and their interpretations
Claim / labelling TGA interpretation ARTG required? Example

The packaging states 'not a medical device' and there is no indication of an intention to prevent transmission of disease between people.

The manufacturer does not intend the product to be used as a medical device. The product is not a medical device.

No

example of a box with the statement 'Not a medical device'

There is a slip in the box of masks stating 'not for medical use'. This slip may be a customs slip. However, the manufacturer has provided information that the intended purpose of the mask is to prevent transmission of disease between people.

The information from the manufacturer with respect to the intended purpose confirms the mask is a medical device.

Yes

example of a slip

There is a slip in the box of masks stating 'not for medical use'. This slip may be a customs slip. The manufacturer has provided information that the intended purpose relates to general consumer use.

The information from the manufacturer with respect to the intended purpose confirms this is not a medical device.

No

example of a slip stating 'not for medical use'

The packaging states 'not for medical use'. However, the manufacturer has provided information that the intended purpose is to prevent transmission of disease between people.

The information from the manufacturer with respect to the intended purpose confirms the mask is a medical device. However, it is not indicated for use in a clinical setting as evidenced by the manufacturer's labelling.

Yes

example of a box with the statement 'Not for medical use'

The packaging states 'not for medical use'. The manufacturer has provided information that the intended purpose relates to general consumer use.

This product is not intended to be used to prevent transmission of disease between persons, nor to be used in a clinical setting as evidenced by the manufacturer's labelling.

No

example of a box with the statement 'Not for medical use'

The packaging states 'not for medical use' and has indications of particle filtration. The manufacturer has provided information that the intended purpose is to prevent transmission of disease between people.

This product is not indicated for use in a clinical setting as evidenced by the manufacturer's labelling. The information from the manufacturer with respect to the intended purpose confirms the mask is a medical device.

Yes

example of a box with the statement 'Not for medical use' and indicating filtration efficiency

The packaging states 'not for medical use' and has indications of particle filtration. The manufacturer has provided further information that the intended purpose is for use in an industrial setting.

This product is not indicated for use in a clinical setting as evidenced by the manufacturer's labelling. This product is indicated to prevent dust particle inhalation.

No

example of a box with the statement 'Not for medical use' and indicating filtration efficiency

The packaging states 'not for medical use' and has indications of bacterial/viral particle filtration. The manufacturer has provided information that the intended purpose is to prevent transmission of disease between people.

The information from the manufacturer with respect to the intended purpose confirms that the mask is a medical device. However, it is not indicated for use in a clinical setting as evidenced by the manufacturer's labelling.

Yes

example of a box with the statement 'Not for medical use' and indicating filtration efficiency

The packaging states 'not for medical use' and has indications of bacterial/viral particle filtration. The manufacturer intends this to prevent microbial transmission from dirt to a person.

This product is not intended to prevent transmission of disease between persons and therefore is not a medical device.

No

example of a box with the statement 'Not for medical use' and indicating filtration efficiency

The packaging states 'not for medical use' and has indications of bacterial/viral particle filtration to prevent transmission of disease from animal origin to human.

The manufacturer does not intend the mask to be used in clinical settings. As the prevention of transmission of disease is not for person to person it is not required to be included in the ARTG.

No

example of a box with the statement 'Not for medical use' and indicating bacterial/viral particle filtration

Labelled as a 'surgical' or 'medical' mask or respirator.

This is representative as suitable for use in surgery, or clinical, medical or other health services.

Yes

example of a box labelled as 'Medical mask'

Labelled as a KN95 / N95 / P2. The manufacturer has provided information that the intended purpose is to prevent transmission of disease between persons or to be used in a clinical setting.

This product is intended to prevent the transmission of disease between people and/or be suitable for use in surgery, clinical, medical or other health services.

Yes

example of a box labelled as 'KN95/N95/P2 mask'

Labelled as a KN95/N95/P2. The manufacturer has provided further information that the intended purpose is for use in an industrial setting.

This product is not intended to prevent the transmission of disease between people nor is it suitable for use in a clinical setting.

No

example of a box labelled as 'KN95/N95/P2 mask'

The TGA post-market review of face masks

The TGA is undertaking a post-market review of face masks to validate the performance of face masks included in the ARTG, to ensure the safety of face mask users. Face masks found not to be medical devices or non-compliant with the safety, quality, and performance requirements will be cancelled from the ARTG. For the latest cancellations, refer to our complete list of cancelled ARTG entries for face masks.

We will continue to provide information on products not fit for purpose. The TGA will not test products no longer included in the ARTG, as the TGA can only request samples of medical devices currently included in the ARTG.

What to do if a face mask is cancelled from the ARTG

The ARTG entry for a face mask may be cancelled by:

  • the sponsor (the person or company legally responsible for supplying the device in Australia) at any time, or
  • the TGA if the product is not a medical device or if there is insufficient evidence to demonstrate the safety, performance, or quality of the device. In this case, the TGA will determine if a product defect notice is appropriate to ensure consumers are aware of the cancellation through the Uniform Recalls Procedures for Therapeutic Goods.

If you have a face mask initially supplied under an ARTG entry which has now been cancelled by the TGA or by the sponsor, you may continue to use it at your discretion, based on your assessment of local circumstances and risk.

Guidance for state and territory government officials

If jurisdictions purchased face masks included in the ARTG, it is at the discretion of the jurisdictions whether those face masks continue to be utilised once an ARTG entry is cancelled. Jurisdictions may have the appropriate documentation to demonstrate the masks meet the specifications/standards for therapeutic use.

The Therapeutic Goods Act 1989 prohibits the further supply of a medical device, by the sponsor, when their ARTG entry has been cancelled. Where jurisdictions have purchased the face masks prior to the cancellation, the subsequent distribution of those face masks by jurisdictions to individuals is not prohibited.

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).