An increased number of individuals and organisations (including major mining companies) have been seeking to import face masks and other types of personal protective equipment (PPE) into Australia during the COVID-19 pandemic. While many legitimate products are being imported, AMSJ and Government regulatory bodies have identified fake respirators entering the market at the early stages of the pandemic.
The following information, provided by the Therapeutic Goods Administration, 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)(link is external).
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.
Remember that the manufacturer determines the intended purpose of PPE. When manufacturers provide information to the TGA that the intended purpose of PPE is to prevent transmission of disease between people, this information confirms the PPE is a medical device, regardless of whether other information, such as a customs slip, is subsequently added to the box stating PPE is ‘not for medical use’.
Include medical devices in the ARTG before importing PPE into Australia
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.
Medical devices must not be imported into or supplied within Australia unless they are included in the ARTG or are the subject of a relevant exemption, approval or authority under the Therapeutic Goods Act 1989.
Some medical devices may be imported into Australia without inclusion in the ARTG if they are covered by the Therapeutic Goods (Medical Devices – Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020(link is external) (the exemption). The only devices covered by the exemption are those to be supplied under a contract between the supplier and the Department of Health, or another agency of the Commonwealth acting on behalf of the Department.
Medical devices for personal importation are exempt from inclusion in the ARTG.
For more information about including medical devices in the ARTG, see:
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.
- 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
This information first appeared on the TGA page here
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