The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Manufacture specific types of medical devices
Information and guidance on the regulation and manufacture of specific types of medical devices.
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PageLinks to information on IVD medical devices, including HIV and nutrigenetic tests.
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Reference materialHow to demonstrate that IVF solutions comply with the Essential Principles for safety and performance.
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PageLinks to information on personalised medical devices (including custom-made, patient-matched, and adaptable medical devices.
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PageInformation and guidance about the regulation of point-of-care manufacturing of medical devices.
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GuidanceGuidance to help sponsors figure out if their therapeutic goods are medicines, biologicals, or medical devices.
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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
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PageLinks to information on the regulation of PPE includes face masks, respirators, gowns, and gloves.
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PageAdvice about systems that are medical devices for sponsors and manufacturers.
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PageInformation for manufactures and sponsors of medical device systems or procedure packs.
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TopicA collection of information about the implementation of medical devices Unique Device Identification (UDI).