China
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application. 

REGULATORY AUTHORITY: Medical devices are regulated by the China Food and Drug Administration (CFDA). 

CLASSIFICATION SYSTEM: Medical devices are divided into Classes I-III according to risk level and amount of testing required, with Class I devices being the lowest risk and Class III devices the highest.

TIMEFRAME: The registration process in China takes about 18 months. 

LICENSE VALIDITY: Licenses are valid for a period of five years.

AUTHORIZED REPRESENTATIVE: An authorized representative is required to register in China.

Last updated on January 7, 2018.



Interested in obtaining fast market approval for your medical device or IVD in China? REQUEST A FREE QUOTE>

For more information on registration in China, check out the following articles on our blog:
5 Questions and Answers: Finding Success in China
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