Medical devices exempt from PFAS ban

An updated statement is available at Updated 'medical devices exempt from PFAS ban' to include other therapeutic goods published on 7July 2025.

From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit the import, manufacture and use of three PFAS chemicals in Australia:

• PFOS (perfluorooctane sulfonate)
• PFOA (perfluorooctanoic acid)
• PFHxS (perfluorohexane sulfonate)

These restrictions support Australia’s obligations under the Stockholm Convention on Persistent Organic Pollutants.

IChEMS does not apply to chemicals used for therapeutic purposes. This means medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the ban.

We encourage manufacturers to reduce the use of IChEMS listed chemicals in medical devices over time but the TGA does not regulate environmental safety. We also encourage sponsors to contact us if they become aware of a potential impact on patients due to a disruption to supply of a medical device due to the IChEMS prohibitions.

More information

For more information contact ichems.enquiry@dcceew.gov.au