About implantable devices
Implantable devices are medical products placed inside the body. Examples include pacemakers, artificial joints, and breast implants.
You must include these devices in the Australian Register of Therapeutic Goods (ARTG) before supplying them.
It is your responsibility to ensure implantable devices are safe, fit for their intended purpose, and will perform as expected throughout their lifecycle.
We evaluate your applications and provide ongoing monitoring and surveillance of device safety to protect public health in Australia.
From 1 July 2026, medical devices are required to have a UDI (Unique Device Identification). Starting with higher risk (class IIb and III) devices, UDI will help us -consumers, health professionals, industry and other stakeholders – easily access device information.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to implantable medical devices. You may also have to meet obligations that apply to all medical devices and all products.
