Medical Device CFDA Registration

1002 标博技术阅读

For all medical devices and in vitro diagnostic reagents(IVD), companies who plan to place medical products on Chinese market must apply for and acquire Medical Device Registration Certificate (Chinese:医疗器械注册证) from the China Food and Drug Administration (CFDA, former SFDA). Foreign firms should designate local legal agent and service agent to deal with registration and after-sales service if there is not subsidiary or representation office in China.

Registration Scope

Any healthcare product meets the definition of medical device or IVD under CFDA regulations and is being to enter the Chinese market. The more information on how to determine the product regulatory obligation in China can be found here

Types of Registration for imported Medical device

Medical Devices	Approval	Testing	Clinical Trial	Authorities	Deadline
Class I	Filing	Self- testing	N/A	CFDA	Pre-market
Class II	Initial Registration	Required	Required	CFDA	Pre-market
	Updates	TBA	TBA	CFDA	Within 1months after being updated
	Renewal	TBA	N/A	CFDA	6 months before the date of certificate expired
Class III	Initial Registration	Required	Required	CFDA	Pre-market
	Updates	TBA	TBA	CFDA	Within 1months after being updated
	Renewal	TBA	N/A	CFDA	6 months before the date of certificate expired

Flow Chart of Medical Device Registration Process

标签: CFDA Registration Medical Device

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