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6 Changes You Must Know: NMPA (CFDA) New Medical Device Classification Catalog

  • 1.  6 Changes You Must Know: NMPA (CFDA) New Medical Device Classification Catalog

    Posted 11-Jan-2019 03:04

    NMPA (CFDA) Medical Device Classification Catalog draft was published August 31, 2017.  A year later, it became effective on August 1, 2018. New registration application after August 1, should follow the new classifications. After the release of the initial Catalog in 2002, CFDA has made several modifications to standardize the classification and streamline the registration process. The new Catalog is the result of several years efforts.

    The new Catalog specifies that "classifications should be based on the Device Category, Subcategory, Example of Device Names, Product Description and Intended Use." Compared with the previous catalog, key changes are:

    1. The number of device categories decreased from 43 to 22.

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    1. 1,157 subcategories are added. For example, Magnetic Resonance Imaging (MRI) machine has 3 subcategories: closed bore (cylindrical), open bore, and dipolar electromagnet.
    2. Product description and intended are added to determine the classification. The difference between sterilized device and non-sterilized one, under same category and subcategory, are shown in the product description.
    3. More examples of device names are provided. The number of device names increased from 1,008 to 6,609.
    4. 40 reclassifications.
    5. Included AI diagnostics for the first time

    IVDs and Companion Diagnostics are not included in the new medical device Catalog.

     

    For CFDA link of Medical Device Catalog, please email info@ChinaMedDevice.com. ChinaMed Device, LLC can help you to identify the product description, intended use, and classification from the catalog.

    For new registration, renewal and modifications, we provide 15 minutes free consultation info@ChinaMedDevice.com.

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    China Med Device, LLC (https://ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies' success.

     



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    Grace Fu Palma
    China Med Device, LLC
    MA, U.S.
    gpalma@chinameddevice.com
    978-390-4453
    www.chinameddevice.com
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