AMERICAS | ASIA PACIFIC | EMEA
Regulatory overview, timeline and fees included in this document current as of May 28, 2015.
China CFDA Market Overview
Medical devices in China are regulated by the China Food and Drug Administration (CFDA). Manufacturers must register their devices with the CFDA prior to commercialization in this market.
Devices are classified into three classes (Class I - Class III), according to risk level.
The CFDA released a new medical device regulation, Order No. 650, which went into force June 1st, 2014. According to this new regulation, Class I devices only require notification to the CFDA, while Class II and III devices require the full registration process, including in-country testing and formal review of the product data. Additionally, in-country clinical trials may also be required for many Class II and III products (explained in more detail further below).
Please bear in mind that the CFDA is continually releasing supporting regulatory guidance on Order No. 650 and changes may occur as new regulations/orders are released.
http://regulatoryaffairs.tebc.com.tw/ra.html
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