Medical Device Registration and Approval in China

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

Medical Device Regulations and Classification in China

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

CLASSIFICATION SYSTEM: The CFDA classifies Medical Devices into three categories Class I, Class II and Class III according to risk level and amount of testing require, with Class I devices being the lowest risk and Class III devices the highest.

TIMEFRAME: The medical device 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.

 

Other Central & East Asia Countries:

Afghanistan, India, Japan, Kazakhstan, Kyrgyzstan, Nepal, Russia, South Korea, Taiwan, Tajikistan, Uzbekistan

 

 

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