Personal protective equipment (PPE) includes face masks, respirators, gowns and gloves.
In Australia, the TGA regulates PPE if a manufacturer makes any of the following claims:
- the PPE is to be used for preventing the transmission of disease between people
- the PPE is suitable for therapeutic use, such as surgical, clinical, or medical use, or use in other health services.
If the manufacturer's labelling, advertising, or documentation contain the claims above, the PPE is considered to be a medical device and is required to be included in the Australian Register of Therapeutic Goods (ARTG).
Personal protective equipment (PPE)
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NewsTherapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021.
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Reference materialInformation to help healthcare organisations update their operating procedures.
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NewsAn overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves
Face masks, hand sanitisers and disinfectants
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PageThis page compiles all our resources related to face masks and COVID-19.
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GuidanceGuidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
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Reference materialUpdated information on using and buying hand sanitisers
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PageList of disinfectants included in the ARTG for use against COVID-19.
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