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
Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II: Selecting the Best Clinical Literature
By Richard Conforti, M.A.
Originally published June 14, 2016
This is the second article 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. In this article we will discuss the changes to selecting clinical literature.
Read More
Nerac Announces Release of the April Issue of the Nerac Strategist
Originally published April 21, 2016
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Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective
By Richard Conforti, M.S., Nerac Analyst
Originally Published: April 19, 2016
Understanding CFDA expectations …what you need to know to market your products in China.
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