CFDA Updates: Draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents” Issued, Along with the 2nd Batch of Clinical Exempt Class II IVD Reagents

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CFDA Updates: Draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents” Issued, Along with the 2nd Batch of Clinical Exempt Class II IVD Reagents

CFDA logoOn May 24,2017, CFDA issued the draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents”. The 2nd batch of clinical exempt class II IVD reagents (130 reagents) have been added to the original clinical exempt IVD reagents directory.

Key highlights are below.

1. Clinical Evaluation Comparison Method

2. Sample Selection and Sample Size

3. Basic Content of the Clinical Evaluation Report

4. Areas that need special attention

For more information,click here to read the entire update.

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