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Registration for CFDA

Discussion in 'China Medical Device Regulations' started by Sing Wee, Jan 8, 2016.

  1. Sing Wee

    Sing Wee Member

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    Hi,

    May I know that the new implant device registration for CFDA require CE mark certificate (compulsory) ?

    thanks
    SW
     
  2. Vintage Goose

    Vintage Goose Active Member

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    I don't know about implants, but IVDs should be CE Marked prior to registration starting.
     
  3. Sing Wee

    Sing Wee Member

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    Thanks

    The device is invasive medical device long term implant (one year implant). Need to know that Class III (according to CFDA) prior CE mark certificate before I enter for CFDA ?

    Thanks
    SW
     

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