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What a manufacturer needs to know about conformity assessment and declarations of conformity for IVDs
Version 1.0, November 2011
TGA Conformity Assessment Certificates are normally issued for a 5 year period.
If the manufacturer intends to continue supplying the devices covered by the certificate in Australia, they need to apply for recertification prior to the expiry date.
An application to re-issue an existing TGA Conformity Assessment Certificate will need to be submitted to the TGA, allowing sufficient time for processing prior to the current certificate expiring. Recertification applications are lodged via the same process utilised for new applications. See Applications for certificates earlier in this Section.
An application fee and assessment fee are payable for the recertification. Assessment fees are levied according to the level of assessment required.
Recertification will normally be associated with an onsite quality management system audit, dependent on the timing of the last TGA surveillance audit.
The manufacturer will be asked to provide a comprehensive concise summary of:
- all design, production and labelling changes implemented since the certificate was issued
- clarification of the current critical suppliers
- stability reports
- performance reports - product/production validation
- postmarket performance data for each device including adverse events, recalls and alerts since the certificate was issued
- review of:
- significance of new safety and performance standards since certification
- risk management file for currency and relevance
- clinical evidence for currency and relevance, including new clinical literature, clinical trial data or other clinical data (e.g. customer surveys etc).