Manufacturers take full responsibility for the design and production of a medical device.
Whether they make the device themselves or subcontract some of these activities.
Device labels must include the manufacturer's name and address.
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PageVarious regulatory requirements and processes apply to the manufacture of medical devices, including in vitro diagnostic (IVD) devices.
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PageInformation for manufactures and sponsors of medical device systems or procedure packs.
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GuidanceGuidance and examples to help you understand the regulatory framework for personalised medical devices.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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Corporate reportsGuidelines for sterility testing of medicines and medical devices supplied in Australia for human use.
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