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Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

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Conformity assessment fees for IHRs

An initial conformity assessment application fee is charged for all applications for a conformity assessment certificate. Relevant fees and charges can be found on the TGA website at Current fees.

An itemised (reduced) fee for examination of the design of IHR IVDs "of the same kind" is prescribed in Schedule 5 Item 1.9A (c) of the Regulations. This fee will be applicable to each application for a design examination for IHR IVDs "of the same kind".

References

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Additional background information on the performance evaluation of Immunohaematology reagents (IHRs) may be found at:

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