This section is for manufacturers of medical devices, including IVDs.
Manufacturers are responsible for the design and production of a medical device. Device labels must have the manufacturer's name and address.
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).