医疗器械FDAUDI食品FDA化妆品FDAVCRP注册化妆品CPNP 加拿大化妆品通报ISO13485体系建立medical device purchasing agent, China medical device sourcing, 

    医疗器械UDI医疗器械FDA化妆品FDAVCRP化妆品CPNP通报|

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    Medical Device CFDA Registration

    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
    ApprovalTestingClinical
    Trial
    AuthoritiesDeadline
    Class IFiling
    Self-
     testing
    N/ACFDAPre-market
    Class II
    Initial
     Registration
    RequiredRequiredCFDAPre-market
    UpdatesTBATBACFDAWithin 1months after being updated
    RenewalTBAN/ACFDA6 months before the date of  certificate expired
    Class III
    Initial
     Registration
    RequiredRequiredCFDAPre-market
    UpdatesTBATBACFDAWithin 1months after being updated
    RenewalTBAN/ACFDA6 months before the date of  certificate  expired
     
    Flow Chart of Medical Device Registration Process
     医疗器械食品化妆品法规服务



    标签:   CFDA Registration  Medical Device
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