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PageIntroductory material on in vitro diagnostic (IVD) medical devices
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PageThis road map presents an overview of the requirements for supplying an IVD for Australian sponsors.
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PageAn overview on Australia's regulatory framework for medical devices, including in vitro diagnostics (IVD) medical devices.
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Corporate reportsThe use Global Medical Device Nomenclature (GMDN) codes for in vitro diagnostic medical devices supplied in Australia.
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PageInformation on the types HIV tests available and guidance for manufacturers and sponsors on clinical performance requirements and risk mitigation strategies for HIV tests supplied in Australia.
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PageRegulatory information and requirements of nutrigenetic tests supplied in Australia.
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PageGuidance for sponsors and manufacturers of in vitro diagnostic medical devices (IVDs) for use in Australia.
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GuidanceGuidance to understand how we interpret regulations and how manufacturers can comply with them.
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GuidanceGuidance explaining sponsor requirements for IVD Conformity Assessment through manufacturer agreements and regulatory compliance.
Product types