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You are here: Home / Archives for Order 650

Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A 3-Part Nerac Perspective

By Richard Conforti, M.S.
Originally published August 15, 2016
This is a 3-part series of articles on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. The third article describes the final clinical literature report.
Read all three here

Webinar: Order 650 – China’s New CLE Requirements for Medical Devices

We invite you to attend our webinar on the clinical literature evaluation process for China.
Learn More Here

Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective Part III: The Final Clinical Literature Evaluation Report

By Richard Conforti, M.S.
Originally published August 15, 2016
This is the third article in a 3-part series on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. This article will describe the final clinical literature report.
Read More

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