In vitro diagnostic (IVD) medical devices

Introductory material on in vitro diagnostic (IVD) medical devices

This road map presents an overview of the requirements for supplying an IVD for Australian sponsors.

An overview on Australia's regulatory framework for medical devices, including in vitro diagnostics (IVD) medical devices.

Information 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.

Laboratory-specific information for the regulation of IVDs.

Regulatory information and requirements of nutrigenetic tests supplied in Australia.