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Personal protective equipment (PPE)
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).
The following resources provide information on PPE, including the regulatory requirements:
- Importing personal protective equipment into Australia during the COVID-19 pandemic
- Guidance on Personal Protective Equipment for Health Professionals
- Regulation of Personal Protective Equipment and COVID-19
- Importing personal protective equipment into Australia during the COVID-19 pandemic
- Emergency COVID-19 exemptions end for ventilators and personal protective equipment
Face masks
Please click on the link below for information on face masks, respirators and gowns.
- PageFace masks and COVID-19This page compiles all of our resources related to face masks and COVID-19.
Hand sanitisers
Please click on the links below for information on hand sanitisers.
- GuidanceHand sanitisers: Information for manufacturers, suppliers and advertisersInformation for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.
- GuidanceHand sanitisers: Information for consumersUpdated information on using and buying hand sanitisers
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