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All medical devices entering the Chinese market are required to obtain pre-market approval, known as medical device registration, from the Chinese Food and Drug Administration (CFDA).[1]
In 2013, the China State Food and Drug Administration (SFDA) formally changed its name to the China Food and Drug Administration (CFDA) with the purpose of controlling several food regulatory bodies and regain consumer confidence.strengthening foreign exchange.[2]
The CFDA is responsible for drafting and supervising regulations for food safety, drugs, medical devices and cosmetics. CFDA regulates standards for medical devices, classification management of medical devices and supervision of such issues as quality and callbacks of medical devices that have entered the market.[3]CFDA’s European counterpart is the European Medicines Agency (EMA) http://www.ema.europa.eu/ema/.
[1]CFDA, www.sda.gov.cn
[2]http://www.sda.gov.cn/WS01/CL0087/89006.html
[3]http://www.sda.gov.cn/WS01/CL0003/
Please note that this guildline has been updated on July, 2014.
