RAPS Convergence 2022

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New IVDs Classification Catalog Draft released by China NMPA

  • 1.  New IVDs Classification Catalog Draft released by China NMPA

    Posted 17-Mar-2023 16:54

    Previously, China NMPA released "In Vitro Diagnostic Reagents Classification Catalog" in 2013 and two supplemental updates in 2017 and 2020 respectively. To keep up with the regulatory and industry development needs brought by new technologies, methods, and biomarkers, NMPA issued the "Classification Catalog for IVD Reagents (Draft)" on March 14, 2023.

    With several years effort by NMPA, the purpose of the new Catalog is to standardize the classification and streamline the IVD registration process. When finalized, all IVD reagents' manufacturers shall comply with the new classifications in the Catalog for their new registration submission in China.

    Compared with the previous catalogs, key changes include:

    1. 25 primary product categories are included in the new Catalog:

    2.There are 2046 secondary product categories, which are classified primarily based on biomarkers for detection. 401 Class III and 759 Class II IVD reagents are included.

    3.The tumor biomarkers for monitoring and prognosis observation are classified as Class II "Reagents for protein detection".

    4.The medium for microbiological identification, such as the chromogenic identification medium added with indicator, is classified as Class II; Microbial culture media for          selective cultivation through the regulation of nutrients or antibiotics is classified as Class I.

    5.'Reagents for sample processing", classified as Class I, mainly refers to the general products used in the sample pre-processing stage before the detection reaction occurs, and does not participate in the reaction. Such products only include reagents for sample processing that are commonly used in the instrument platform or methodology and exclude reagents that are specific to certain detection items for sample processing.

    6. "General reagents for reaction system", classified as Class I, mainly refers to the general reagent used to maintain the reaction system environment in the detection reaction stage. General reagents only include reaction system reagents that are commonly used in the instrument platform or methodology, such as substrate solution for chemiluminescent immunoassay, luminescent solution for chemiluminescent immunoassay, etc., not specific to certain detection items.

    Feedbacks to NMPA on the IVD Classification Catalog (Draft) need to be submitted by April 20, 2023. Please email your feedback or any questions regarding the new Catalog to me.

    We can help to consolidate and send the feedback to NMPA. Ensuring your devices are covered by the classification catalogue is very important as it is the foundation to determine your classification. If your types of devices are not reflected in it or not as accurately or completely as they should be, this is the time for you to give your feedback!



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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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