An increased number of individuals and organisations have been seeking to import face masks and other types of personal protective equipment (PPE) into Australia during the COVID-19 pandemic. This page outlines what you need to know before you seek to import PPE.
PPE regulation in Australia
PPE and the Australian border
The Australian Border Force (ABF) and the Therapeutic Goods Administration (TGA) work collaboratively to ensure Australians have access to critical goods, such as the importation of legitimate PPE.
If an ABF officer suspects goods may contravene the Therapeutic Goods Act 1989, the goods are detained at the border and referred to the TGA for assessment.
The TGA has the power to request that the ABF treat the goods as a forfeited good under section 229 of the Customs Act 1901 or to release the goods.
PPE that is regulated as a medical device
In Australia, the TGA regulates PPE as a medical device 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.
In most cases, medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally import them into Australia for commercial use or supply. The same requirement applies for exporting medical devices from Australia or manufacturing or supplying medical devices in Australia.
PPE that is not regulated as a medical device
Not all PPE is a medical device. For example, reusable cloth masks and single-use face masks - including those worn by painters, gardeners and other occupations working in a dusty environment - do not need to be included in the ARTG.
However, any product that is claimed to prevent the transmission of disease (including by controlling the spread of bodily fluid, droplets, bacteria or viruses) on its label, accompanying documentation or its advertising is likely to be regarded by the TGA as a medical device, regardless of the intended use by the importer.
Finding out more about PPE regulation
For more detailed guidance on PPE regulation, see:
- Regulation of personal protective equipment and COVID-19
- Face masks and respirators that are regulated by the TGA.
Importing PPE for personal use
We do not recommend buying PPE from overseas websites for preventing the transmission of disease. Products from overseas websites could be ineffective or unsafe.
