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To manufacture an in vitro diagnostic (IVD) medical device for supply in Australia, you must meet safety, quality and performance requirements.
Your IVD must be made under acceptable conformity assessment evidence issued by the TGA or a comparable overseas regulator.
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.