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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs

Version 1.0, November 2011

24 November 2011

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Next steps

Once the TGA Conformity Assessment Certificate is issued to the manufacturer, the Australian sponsor of the device will be required to register the certificate as conformity assessment evidence (manufacturer's evidence) with the TGA through the e-Business system. For more information please see Section - What a sponsor needs to know about conformity assessment and manufacturer's evidence for IVDs.

Once the certificates are accepted, the Australian sponsor can proceed with an application to include the medical device in the ARTG. The device cannot be legally supplied to the market in Australia unless the application for inclusion is approved, as a valid ARTG entry must exist prior to supply.

No further assessment will be conducted by the TGA for IVDs that are covered by a TGA Conformity Assessment Certificate.

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