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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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Depth of information to be provided

The following table summarises the depth of detail required to be contained in the STED for a product undergoing conformity assessment by the TGA. References to Class 4 IVDs in this table indicate the level of detail expected in the design dossier for products undergoing a design examination.

Section Class 1 Class 2 Class 3 Class 4
Device description including variants
Device description Address each point - all classes
Reference to previous device generation - not yet available on any market SUMMARY SUMMARY SUMMARY SUMMARY
Device history - already available on the market in another jurisdiction SUMMARY SUMMARY SUMMARY SUMMARY
Risk analysis and control SUMMARY / REDUCED TABLE DETAILED
Design and manufacturing information
Device design SUMMARY SUMMARY SUMMARY DETAILED
Clinical evidence SUMMARY SUMMARY DETAILED ELABORATE
Manufacturing processes - - - SUMMARY
Design and manufacturing sites SUMMARY SUMMARY SUMMARY SUMMARY
Product validation and verification
Specimen type SUMMARY SUMMARY SUMMARY DETAILED
Accuracy - Trueness SUMMARY SUMMARY DETAILED DETAILED
Precision - Reproducibility and repeatability SUMMARY SUMMARY DETAILED DETAILED
Traceability of control and control materials SUMMARY SUMMARY SUMMARY DETAILED
Analytical sensitivity SUMMARY SUMMARY DETAILED DETAILED
Analytical specificity SUMMARY SUMMARY DETAILED DETAILED
Measuring range of the assay SUMMARY SUMMARY DETAILED DETAILED
Validation of assay cut-off SUMMARY SUMMARY DETAILED DETAILED
Software SUMMARY SUMMARY SUMMARY DETAILED
Stability
Claimed shelf life SUMMARY SUMMARY DETAILED DETAILED
In use stability SUMMARY SUMMARY DETAILED DETAILED
Shipping stability SUMMARY SUMMARY DETAILED DETAILED

The following information elaborates on the terms used in the table to describe the depth of detail:

Summary information

  • Brief description of protocol
  • Study results
  • Study Conclusion

Detailed information

  • Study protocol
  • Method of data analysis
  • Study report (summary of external reports)
  • Study Conclusion

Elaborated information

  • Study protocol
  • Method of data analysis
  • Study report (all external reports)
  • Study Conclusion
  • Raw/line data

The following table shows the terms used for the various devices classes in the GHTF document and their equivalents for IVDs under the Australian regulations.

GHTF IVD Class Australian IVD Class
Class A Class 1 IVD
Class B Class 2 IVD
Class C Class 3 IVD
Class D Class 4 IVD

The STED should demonstrate the compliance of the IVD with the Australian legislative requirements. An EP Checklist for the Australian Essential Principles is available on the TGA website.

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