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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.

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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.

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Overview of medical devices and IVD regulation
Product types