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NMPA: UDI for Class II Devices Starting June 1, 2024

  • 1.  NMPA: UDI for Class II Devices Starting June 1, 2024

    Posted 23-Feb-2023 18:47

    Started from January 1, 2021, 69 high-risk class III devices were included in the UDI application of First Batch of Devices. After that, UDI has been implemented in all Class III devices and IVDs,effective from June 1, 2022. 

    Overseas manufacturers need to register their devices in the China national UDI database. In essence, after you get your NMPA registration approval, both UDI and NHSA are needed in order to sell into public hospitals. 

    China NMPA recently made an announcement on November 30, 2022mandating many Class II devices to meet UDI submission requirements. The final list was released by NMPA on February 10, 2023.

    The document "Implementation of the Third Batch of Medical Devices UDI", requires manufacturers to submit UDI application for the following Class II devices:

    1.         Disposable products with high volume clinical usage

    2.         Selected products for volume based purchasing

    3.         Medical aesthetic products

    The notice says that for class II devices:

    1.     Class II and Class III devices manufactured after June 1, 2024, shall have unique identifiers.

    2.     Devices manufactured before June 1, 2024, are not required to have unique identifiers.

    3.        Starting June 1, 2024, for initial registrations, renewal and modification registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system.

    Below are the Third Batch Devices:

    1.         Ultrasound surgery equipment accessories

    2.         Medical laser

    3.         High-frequency surgical equipment

    4.         Argon protection aerocoagulation equipment

    5.         Electrodes and catheters for high frequency/radio frequency

    6.         Perfusion pumps for RF ablation equipment

    7.         Active devices for endoscopic surgery

    8.         Electric stapler

    9.         Stapler (with nails)

    10.     Stapler (without spikes)

    11.     Vascular suture device

    12.     Non-absorbable sutures

    13.     Lithotomy instruments for endoscopy

    14.     Bladder catheters for endoscopes

    15.     Balloon compression device for balloon dilation catheters

    16.     Orthopedic endoscope with a knife

    17.     Orthopedic power surgery equipment

    18.     Urinary X-ray machine

    19.     Laser treatment equipment

    20.     Cardiac rhythm management program-controlled devices

    21.     Neuromodulation program-controlled devices

    22.   Pen injectors

    23. Pocket tension ring implant device

    24.     Gynecological prosthetic devices

    25.     Blood cell analysis instruments

    26.     … …

    Love to hear your experience if you have gone through class III devices UDI requirements, any challenges or questions you may have for the upcoming class II devices UDI.



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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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