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China NMPA down-classified 29 Invitro-Diagnostics Reagents

  • 1.  China NMPA down-classified 29 Invitro-Diagnostics Reagents

    Posted 23-Oct-2020 10:45

    NMPA published an announcement about the modification of In vitro diagnostics (IVD) reagents classification catalog on October 20, 2020. The IVD reagents classification catalog, "6840 In Vitro Diagnostics Reagents Classification Sub-catalog" was first published in 2013. The 2013 classification catalog divides IVD reagents into 22 categories. The modification of the catalog only impacts the tests in category III-7, tumor biomarkers related reagents. 29 out of 48 tests in this category have been down-classified from Class III to Class II medical devices. Examples include carcinoembryonic antigen (CEA) tests, squamous cell carcinoma antigen (SCC) tests, human epidydimal protein 4 (HE4) tests, etc. NMPA also modified the intended use of these 29 tests. If you are not sure whether your product is affected by this modification, please let me know.



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    Grace Fu Palma
    ChinaMed Device, LLC
    MA, U.S.
    gpalma@ChinaMedDevice.com
    978-390-4453
    www.ChinaMedDevice.com
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