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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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TGA Conformity Assessment Certificates are subject to ongoing surveillance of the manufacturer and its products by the TGA.

Normally the initial onsite audit of a manufacturer is a full audit covering all applicable aspects of the manufacturer's quality management system.

Surveillance audits normally occur approximately every 18 months after certification, but may occur more frequently depending on the manufacturer's compliance status and the risk class of the products. Surveillance audits are normally shorter audits and do not cover every applicable aspect of the quality management system. Surveillance activities may also be associated with product compliance monitoring activities, such as monitoring of non-standard conditions on the certificate, or follow-up of post-approval recommendations and agreements.

For overseas manufacturers, the TGA may request EU Notified Body or CMDCAS registrar audit reports, with the view to abridging the TGA surveillance activities. If those reports are available, and provide evidence of a thorough and comprehensive assessment, then the TGA may abridge the surveillance activities and charge reduced fees. However, the TGA reserves the right to conduct its own surveillance irrespective of such reports.

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