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You are here: Home / Archives for regulatory compliance

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.
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Nerac Announces Release of the June Issue of the Nerac Strategist

Originally published June 22, 2016
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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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Nerac Announces March Issue of The Nerac Strategist

Originally published March 17, 2016
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Nerac announces January Issue of the Nerac Strategist

Originally published January 26, 2016
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Nerac Announces New Issue of The Nerac Strategist

Originally published November 19, 2015
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Nerac Announces September Issue of The Nerac Strategist

Originally published September 15, 2015
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Upcoming Event: Notified Body Expectations: Today, Tomorrow and into the Future

R&Q and Nerac invite you to join medical device professionals from GE Healthcare, MAQUET, Nerac and R&Q for a morning of informational sessions which will cover the regulatory changes which have driven the increasing demands and changing expectations of Notified Bodies, and what companies are doing to meet compliance.

Thursday, June 18, 2015
7:30am to 11:00am (EST)
Embassy Suites Waltham, Waltham, MA
Learn More.

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