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China NMPA: Modified its Classification Catalogue, Cosmetic Devices Impacted

  • 1.  China NMPA: Modified its Classification Catalogue, Cosmetic Devices Impacted

    Posted 14-Jul-2022 12:32


    On March 30, 2022, NMPA announced modification to its medical device classification catalog. 27 categories are impacted, 16 of which are cosmetic device related. The changes in the 27 categories include reclassifications, product descriptions and intended uses. It also specified more compliance requirements mandated to report to the provincial MPA.

    If you are in cosmetic industry, please notice the implementation of date of April 1, 2024 as certain cosmetic devices in home use cannot be sold anymore in China unless you obtain the medical device registration certificates.

    1. Radiofrequency therapy

    Starting from April 1, 2024, radiofrequency devices or RF devices and RF skin devices classified under classification code 09-07-02, shall not be produced, imported, or sold without obtaining medical device registration certificates. The relevant registrants of RF devices shall fulfill the responsibility of the product quality and comprehensively strengthen the quality management of the whole product life cycle to ensure safety and effectiveness once products are listed.

    For transition under the newly modified categories, registrants shall report proactively to the provincial Medical Product Administration (MPA) where the legal representative is located.

    1. Other cosmetic devices

    Starting from March 30, 2022, other cosmetic devices reclassified in this modification shall be registered under the newly modified categories. If you would like detailed information about initial and renewal registration changes resulted by the reclassification, feel free to contact me.

    Impacted cosmetic devices are listed below:

    1. RF device
    2. Artificial bone
    3. Bone repair material
    4. Hydroxyapatite bioceramics
    5. Calcium phosphate bioceramics
    6. Β-Tricalcium phosphate artificial bone
    7. Calcium sulfate artificial bone
    8. Collagen-based bone repair material
    9. Calcium phosphate bone cement
    10. Bioglass Bone Filler
    11. Sodium hyaluronate solution for injection
    12. Facial implant
    13. Face lift
    14. Facial cone lifter
    15. Osteo inductive calcium phosphate bioceramics
    16. Chitosan solution for joint cavity

    I'd love to hear your thoughts and your plan to transition those cosmetic devices that changed their status from non-medical devices to medical devices.



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


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