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China NMPA Innovation Pathway for Medical Devices China NMPA Innovation approved devices enjoy premium pricing

  • 1.  China NMPA Innovation Pathway for Medical Devices China NMPA Innovation approved devices enjoy premium pricing

    Posted 27-Oct-2022 20:53
    Edited by Grace Fu 27-Oct-2022 20:53

    Innovation approval pathway is one of the several NMPA green pathways for faster approval in medical devices.


    Innovative Product criteria

    To be qualified for "innovative medical device", the device should meet three major criteria:

    1. Patent
      1. The applicant owns legal patent rights of the product's core technology in China or obtains legal patent use right in China.
      2. Otherwise, core technology of the patent is published by the Patent Administration Department of the State Council.
    2. Product
      1. Complete the preliminary research of the product and has a product prototype with traceable data
    3. Significant clinical value
      1. The main working principle or mechanism of the product is pioneering in China. The performance or safety of the product is fundamentally improved compared with similar products. It has advanced technology globally with significant clinical value.

     

    Innovation Approved Products are Exempted from Volume-Based Procurement (VBP)

    The National Healthcare Security Administration released the "Reply"[1] regarding the impact of VBP on the innovative medical devices on September 3, 2022.

    The "Reply" indicated, since the clinical application of the innovative medical device has not yet mature, it is difficult to predict the usage and implement VBP. , The product considered innovative will unlikely to be the subject of VBP, or to face a price reduction, and will have extra market space for development.

    Considerations of Innovation Approval Green Pathway

    Overseas manufacturers should bear in mind that:

    1. Overseas applicants share equal opportunity and qualification with the domestic applicants for fast-track channels.
    2. Overseas clinical trial data can be used to minimize or avoid China local clinical trial if the study meets overseas clinical data acceptance guideline.

    We could appreciate to hear your comments on your past experience with innovation approval as it is more important now to use innovation approval pathway for premium pricing.

    [1] "Reply of the National Medical Security Administration to Recommendation No. 4955 of the Fifth Session of the Thirteenth National People's Congress", in short, the "Reply".



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


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