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