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Conformity assessment procedures for immunohaematology reagents
Version 1.0, February 2012
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".
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- UK Red Book
Guidelines for the Blood Transfusion Services in the UK
- Anti-A minimum potency reference preparation (pdf,254kb)
WHO International Standard or Reference Reagent 03/188
- Anti-B minimum potency reference preparation (pdf,254kb)
WHO International Standard or Reference Reagent 03/164
- Anti-Human Globulin (pdf,221kb)
WHO International Standard or Reference Reagent 96/666
- Anti-D Minimum Potency Standard for blood grouping reagents (pdf,211kb)
WHO International Standard or Reference Reagent 99/836
- Papain reference preparation 92-658 (pdf,218kb)
ISBT/ICSH Reference Material 92/658
- Common Technical Specifications for in vitro diagnostic medical devices (pdf,101kb)
Revision of the common technical specifications laid down in Decision 2002/364/EC
Additional background information on the performance evaluation of Immunohaematology reagents (IHRs) may be found at: