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You are here: Home / Nerac Insights / Articles / Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective

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

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By Richard Conforti, M.S., Nerac Analyst,
Originally Published: April 19, 2016

In 2014 the Chinese Food and Drug Administration, CFDA, updated their regulations on medical devices. These updates substantially changed the way in which a medical device company, particularly international companies not based or founded in China, registers their devices in China.

In part 1 of this 3 part series, the author explores the new regulations, and ways to address changes in the registration process.

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