To manufacture or supply an in vitro diagnostic (IVD) medical device in Australia, you must meet safety, quality and performance requirements.
You must have acceptable conformity assessment evidence issued by the TGA or a comparable overseas regulator authority. You also need reliable supply and distribution processes.
IVDs must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempt. Exported IVDs may need an export certificate.
Understanding these rules can help you manage your supply chain risks and meet your legal obligations.
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.
Supply
Understand your obligations to manage the ongoing supply of products.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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PageGuidance on legally supplying medical devices in, and exporting them from, Australia.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
Import and export
Access requirements for import and export of therapeutic goods.
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FormsApply for a Certificate of Free Sale or an Export Certificate for a medical device.
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PageInformation for manufacturers and sponsors on COVID-19 rapid antigen tests (RATs) regulatory requirements and processes.
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PageTo export medical devices, including in-vitro diagnostic medical devices (IVDs) and other therapeutic goods (OTGs), you must meet requirements set out in the Australian therapeutic goods legislation.
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PageInformation for health professionals importing and supplying medical devices.
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PageAn overview of the requirements for importing COVID-19 rapid antigen tests into Australia