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After your in vitro diagnostic (IVD) device is on the market, you have ongoing responsibilities to meet regulatory requirements.
You must:
manage your device’s inclusion in the Australian Register of Therapeutic Goods
pay regulatory charges
notify us of any changes or variations to your product
monitor safety and report issues
support post-market surveillance
We oversee monitoring and compliance activities to protect public health. Understanding your responsibilities helps you stay compliant and ensures IVDs remain safe in Australia.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to IVDs. You may also have to meet obligations that apply to all medical devices and all products.