Importing personal protective equipment into Australia during the COVID-19 pandemic

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.

For more information, see:

• Buying medicines and medical devices online
• PPE buyers guide (Department of Industry, Science, Energy and Resources).

Importing PPE for commercial purposes

If you are seeking to import PPE into Australia for commercial purposes (including for the purposes of supplying PPE to your employees), it is important to understand your regulatory obligations. If you breach import requirements, border officials may seize and destroy your goods. You could also face fines and other penalties. More serious offences can result in criminal prosecution or civil penalties.

For more information, see Compliance actions and outcomes.

Determine if PPE is a medical device

Before you import, you will need to determine if the PPE you are seeking to import is a medical device (see above). In most cases, if the PPE is a medical device, you must include it in the ARTG before you import it.

Use the interactive decision tool to help determine if your product is a medical device.

If PPE is not a medical device, clearly state its intended use

If the PPE is not a medical device, you can facilitate processing of your import at the Australian border by providing clear documentation in the package. Your documentation should clearly state the intended use of the PPE. For example, dust masks for use in an industrial setting should be clearly described as such.

Include medical devices in the ARTG before importing

You must include medical devices in the ARTG before you import the goods for commercial purposes. Medical devices cannot be included in the ARTG retrospectively.

To include PPE that is regulated as a medical device in the ARTG, you will need to assume the role of a sponsor, and you will also need to establish an ongoing relationship with the manufacturer to be able to request and provide information about the PPE to the TGA. Note that currently all face masks are subject to post-market review.

For more information about including medical devices in the ARTG, see:

• Regulation of personal protective equipment and COVID-19
• Medical device inclusion process.

For additional guidance about evidence requirements of face masks and respirators, see:

• Evidence requirements for face masks that are medical devices
• Guidance on medical/surgical face masks and respirator standards - key performance aspects

Ensure imported medical devices match your ARTG entry

All relevant details of the medical devices you are importing should match your ARTG entry. In particular, the manufacturer of the imported goods must be the same as the manufacturer stated in the ARTG entry. The intended purpose of the device on your ARTG entry should also be in alignment with the manufacturer’s intended purpose.

Include an ARTG certificate in your import documentation

Once a medical device is included in the ARTG, you can facilitate processing of your import at the Australian border by including the ARTG certificate in the package. Including the ARTG certificate is not a requirement, but it can help facilitate timely processing of your import.

Useful links

• Regulation of personal protective equipment and COVID-19
• Face masks and respirators that are regulated by the TGA
• Post-market review of face masks: Overview
• When to engage with the TGA
• TGA Business Services: getting started with the TGA
• Medical device inclusion process

For more information about face masks visit Face masks and COVID-19.