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
- 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
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Importing personal protective equipment into Australia during the COVID-19 pandemic
Therapeutic Goods (Medical Devices - Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 ceases on 31 January 2021. -
Personal protective equipment for health professionals
Information to help healthcare organisations update their operating procedures. -
Regulation of personal protective equipment and COVID-19
An 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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Face masks and COVID-19
Guidance on face masks and COVID-19 in Australia, including when masks are regulated as medical devices, ARTG requirements, safety alerts, and resources for consumers, health professionals and industry. -
Meeting requirements to manufacture, supply or advertise hand sanitisers
Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations. -
Disinfectants for use against COVID-19 in the ARTG for legal supply in Australia
List of disinfectants included in the ARTG for use against COVID-19.
Product types
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