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.
In part 2 of this 3 part series, the author discusses the changes to selecting clinical literature.
In the 3rd installment of this 3 part series, the author describes the final clinical literature report.
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