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Once your implantable medical device is included in the Australian Register of Therapeutic Goods (ARTG) and supplied to the Australian market, you have ongoing regulatory responsibilities.
You must:
manage your device’s inclusion in the ARTG
pay ongoing charges
notify us of any changes or variations to your registered device
monitor the safety and performance of the device and report any deterioration in performance
maintain records and report adverse events that have caused or may cause injury or unintended harm.
maintain appropriate Quality management systems (QMS) to support post-market surveillance
We oversee monitoring and compliance activities to protect public health.
Understanding your responsibilities and our role helps you stay compliant and keeps implantable devices safe and effective in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.