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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.