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  • 1.  China regulations for IVD clinical trials

    This message was posted by a user wishing to remain anonymous
    Posted 26-Oct-2017 14:59
    This message was posted by a user wishing to remain anonymous

    Is country of origin approval needed to initiate a clinical trial in China for an IVD that is used as a companion diagnostic?


  • 2.  RE: China regulations for IVD clinical trials

    Posted 27-Oct-2017 10:37

    Administrative Measures on the Registration of IVD Reagents

    Article 15 The imported IVD reagents in application for registration or in filing formalities shall have been approved to be listing and sale at the place where the applicant or filing applicant is registered or at the country (region) where the production site is located.

    Generally speaking, you should use lots that are produced after the product is registered/listed (whether in the country where the legal manufacturer is located or the country where the actual production is located) for type testing. After obtaining the type test report, you can apply EC approval for your clinical trial, which normally requires you to provide the proof of registration in your country of origin.

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    Qianqian Zhu RAC
    United States
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    Original Message


  • 3.  RE: China regulations for IVD clinical trials

    Posted 27-Oct-2017 12:10
    As IVD used as a companion diagnostic, you still need to get 510K or PMA first then initiate CFDA registration. For CFDA registration,  you need to do Type Testing in CFDA Testing Lab, after getting CFDA Testing Report you could start to do Clinical Trial in China. If the Clinical Trial data you had outside China could meet CFDA requirements, they could be used as reference data to support CFDA submission.

    A smart and strategic registration plan is very important for CFDA registration, especially for the clinical trial.

    Hope it is helpful for you.

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    Julia Niu
    Ramed Bioscience,
    Cambridge, MA
    United States
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    Original Message


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