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Depth of information to be provided

Version 1.0, November 2011
Last updated

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.

SectionClass 1Class 2Class 3Class 4
Device description including variants
Design and manufacturing information
Product validation and verification
Stability
Device descriptionAddress each point - all classes
Reference to previous device generation - not yet available on any marketSUMMARYSUMMARYSUMMARYSUMMARY
Device history - already available on the market in another jurisdictionSUMMARYSUMMARYSUMMARYSUMMARY
Risk analysis and controlSUMMARY / REDUCED TABLEDETAILED
Device designSUMMARYSUMMARYSUMMARYDETAILED
Clinical evidenceSUMMARYSUMMARYDETAILEDELABORATE
Manufacturing processes---SUMMARY
Design and manufacturing sitesSUMMARYSUMMARYSUMMARYSUMMARY
Specimen typeSUMMARYSUMMARYSUMMARYDETAILED
Accuracy - TruenessSUMMARYSUMMARYDETAILEDDETAILED
Precision - Reproducibility and repeatabilitySUMMARYSUMMARYDETAILEDDETAILED
Traceability of control and control materialsSUMMARYSUMMARYSUMMARYDETAILED
Analytical sensitivitySUMMARYSUMMARYDETAILEDDETAILED
Analytical specificitySUMMARYSUMMARYDETAILEDDETAILED
Measuring range of the assaySUMMARYSUMMARYDETAILEDDETAILED
Validation of assay cut-offSUMMARYSUMMARYDETAILEDDETAILED
SoftwareSUMMARYSUMMARYSUMMARYDETAILED
Claimed shelf lifeSUMMARYSUMMARYDETAILEDDETAILED
In use stabilitySUMMARYSUMMARYDETAILEDDETAILED
Shipping stabilitySUMMARYSUMMARYDETAILEDDETAILED

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 ClassAustralian IVD Class
Class AClass 1 IVD
Class BClass 2 IVD
Class CClass 3 IVD
Class DClass 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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This webpage on the TGA website was printed on 10 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/resource/guidance/what-manufacturer-needs-know-about-conformity-assessment-and-declarations-conformity-ivds/depth-information-be-provided

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