Register for Upcoming Webinar on DEC. 8 @ 11AM

2024 China NMPA Bluebook is here:

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.

China Med Device, LLC, specializing in providing turn-key solutions for medtech companies entry into China, brings you up to date information on CFDA. If you have any feedback, please email us at or visit us at

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox