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IVD Clinical Trials in China

Discussion in 'Other Medical Device Regulations World-Wide' started by Sreenu, Jul 31, 2015.

  1. Sreenu

    Sreenu New Member

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    Hi All,

    First of all, thanks Atul:)

    I am looking at the detailed information for Class III IVD clinical trials in China for a foreign manufactured IVD - how many centres(2 or 3); what is the sample size; any prior approvals before starting the trials; how much does it cost; how long does it take; etc..

    Thanks,
    Sreenu
     
  2. Stephen Chung

    Stephen Chung New Member

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    Believe it's minimum of two CFDA approved centers. Need IRB approval before starting the trials and the cost needs to be worked out between you and the hospitals. For certain products, national standards, which specifies the number of samples and procedure, are available. Nobody knows how long clinical trials take but depending on the nature and number of samples, it may take anywhere from 6 months to 18 months. It's a long and difficult process and you should try finding a competent/established registration agent/consultant in China who is fluent in English and Chinese.
     
  3. Vintage Goose

    Vintage Goose Active Member

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    Hi, I believe the fee for a class III IVD clinical trial is around 43,200 RMB, and the fee for registration is 308,800 RMB. The registration fee needs to be applied both to a test kit and separately to controls.

    My notes says 3 CFDA approved centers (all AAA class local hospitals), with IRB approval. At least 1140 test cases for each IVD reagent.

    Don't forget the laboratory testing that is required as well.

    The requirements are very fluid and poorly defined. You definitely need a local (Chinese speaking) agent, who is on your side, to negotiate with CFDA.

    Overall, you are looking at 100-150,000 euros and 2-3 years for each assay.
     

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