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.
* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.