Overview:

Non-sterile face masks are regulated as medical devices under the Therapeutic Goods Act of 1989. Importation, distribution or exportation of any goods are required to be included in the ARTG (Australian Register of Therapeutic Goods). Face masks used for the community, reusable cloth mask and single-use face masks when social distancing is not possible are not subject to the same regulations as surgical masks or respirators and need not be included in ARTG. Face masks claiming ‘not for medical use’ on labels, are exempted from ARTG listing. Although, these masks are used to prevent diseases between people but in a non-clinical setting.

TGA Regulatory Authority:

TGA regulates and exempts face masks depending on the intended use.

Face mask regulated by TGAFace mask exempt from TGA regulation

Manufacturers claiming the following will be considered a medical device:

  • Is used to prevent transmission of disease between people
  • Can be used for therapeutic use such as surgery, clinical or medical use

Face mask that are intended to be used as safety or personal protective equipment (PPE) and do not claim any requirement of a medical device.

These are excluded from TGA under Therapeutic Goods (Excluded Goods) Determination 2018.

 NOT required for ARTG Registration:

The following is a list of claims that differentiate on which claims need ARTG registration and those NOT required for ARTG Registration.

  • The packaging states, ‘not a medical device’ and there is no indication of an intention to prevent transmission of disease between people.
  • 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 packaging states ‘not for medical use’. The manufacturer has provided information that the intended purpose relates to general consumer use.
  • 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.
  • 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.
  • 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.
  • Labelled as a KN95/N95/P2. The manufacturer has provided further information that the intended purpose is for use in an industrial setting.

Required to be listed under ARTG

  • 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 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 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.
  • 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.
  • Labelled as a ‘surgical’ or ‘medical’ mask or respirator.
  • 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.

Post-Market Review:

Post market review of by TGA is done to validate the performance to ensure safety of the consumers. Face masks not complying with TGA’s safety, quality or performance can be removed from ARTG list.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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