2.SFDA Medical Device Classification

SFDA categorizes medical products in three classes and requires different materials at registration:

Product Class Description
Class I They are devices whose safety and effectiveness can be ensured through routine administration; They don't need to do the Type Testing in China .
Class II They are the products whose further control is required to ensure their safety and effectiveness, and need to do the Type Testing in China .
Class III They are those, which are implanted into the human body, or used for life support or sustenance, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness.

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