By Richard Conforti, M.S., Nerac Analyst,
Originally Published: April-August, 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.
Want to read the rest of the article? Fill out the form to download:Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective
In part 2 of this 3 part series, the author discusses the changes to selecting clinical literature.
Want to read the rest of the article? Fill out the form to download:Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II
In the 3rd installment of this 3 part series, the author describes the final clinical literature report.
Want to read the rest of the article? Fill out the form to download:Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part III
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