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Overview of the regulatory framework for IVDs

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

The regulatory framework for medical devices including IVD medical devices spans the life of the device and includes:

  • pre-market assessment: conformity assessment
  • market authorisation: inclusion in the ARTG
  • post-market monitoring: continuing compliance with all regulatory, safety and performance requirements and standards.

For details go to Overview of medical devices and IVD regulation.

For details on how IVDs are classified go to Classifying IVDs.

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