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China NMPA Guideline on Modification Registration of IVD Reagents Asks Your Feedback

  • 1.  China NMPA Guideline on Modification Registration of IVD Reagents Asks Your Feedback

    Posted 22-Jun-2023 14:01

    China NMPA issued the "Draft Guideline on Modification Registration of In Vitro Diagnostic Reagent" on May 31, 2023. Feedback needs to be submitted by June 30, 2023.

    Decision-making Modification Registration IVD Flowchart

    Changes in IVD reagents should be controlled through the quality management system, and if the changes occur on medical device registration certificate and its annexes, modification filing or modification registration is required.


    Changes in the name and address can be applied through modification filing, and other content changes shall be applied through modification registration approval.

    Consideration to be Given:

    The following situations need to be considered in the process of risk control and technical evaluation.

    Circumstances that do not increase risks:

    • Textual changes in product names.
    • Changes in packaging specifications that do not affect performance or stability: the minimum packaging of the product composition remains unchanged, only the number of packaging changes.
    • Add warning information to the manual.
    • Delete the applicable model.
    • The text change of the production address of imported IVD reagents.
    • Other changes that do not affect the performance of the product.

    Circumstances where there is potential risk:

    • Packaging specification changes
    • Changes in product storage conditions and expiration date
    • Applicable instrument changes
    • Positive judgment value or reference interval change
    • Changes in raw materials of Class III IVD reagents
    • Changes in the production process of Class III IVD reagents
    • Changes in the reaction system
    • Change of production address of imported IVD reagents
    • Applicable sample type change
    • Changes in applicable population and clinical indications
    • Changes in product technical requirements and instructions

    Modification Examples

    In the draft guideline, NMPA takes below as examples to demonstrate in which scenarios, applicants shall submit modification application in terms of modification description, non-clinical and clinical trial:

    1. Changes to applicable instruments
    2. Changes in raw materials for Class III IVD reagent
    3. Changes in the reaction system
    4. Changes of clinical indications
    5. Changes to other products used in companion with the reagent
    6. Changes of reference interval
    7. Changes to the sample types and clinical indications
    8. Add calibrators

    Regarding the draft guideline on Modification Registration IVD, if you have any feedback, please email me before June 30, 2023. I can help you submit to NMPA. 



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


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