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Conformity assessment procedures for immunohaematology reagents

Version 1.0, February 2012

29 February 2012

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Overview

The TGA has published the following regulatory guidelines for manufacturers and sponsors of in vitro diagnostic (IVD) medical devices on the TGA website:

There are some specific requirements in the regulation of immunohaematology reagents (IHRs) that manufacturers and sponsors need to consider when applying conformity assessment procedures or making applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). These requirements are specifically addressed in this guideline which is designed to be read in conjunction with the other published guidelines referenced above.

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