New Australian IVD regulations by year's end?

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  • Additional Information
    • Subject Terms:
      AUSTRALIA
    • Subject Terms:
      THERAPEUTIC Goods Administration (Australia)
    • Abstract:
      The article looks at the Australian Therapeutic Goods Administration's (TGA) plans for a new regulatory framework for in vitro diagnostic devices (IVDs). It says that the Australian regulatory body plans an end of 2009 implementation date with a four-year transition period before the new framework becomes mandatory. It says that the framework will be brought within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002.