RAPS Convergence 2022

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China Medical Electrical Standards Effective May 1, 2023; Grace Period Granted

  • 1.  China Medical Electrical Standards Effective May 1, 2023; Grace Period Granted

    Posted 24-Mar-2023 18:04

    On March 16, 2023,  China NMPA issued the "Notice on Implementation of GB 9706.1-2020 and Supporting Standards", equivalent to IEC60601 with effective date of May 1st, 2023.  Good news for active product manufacturers with existing NMPA  certificates, grace period has been granted to comply by  December 31, 2025.

    The Impact of GB 9706.1-2020 and Supporting Standards in China

    GB 9706.1-2020 and Supporting Standards is a mandatory standard. If products are applicable to GB 9706.1-2020 and its related standards, they can be implemented with the last implemented standard at the same time. If products are not applicable to GB 9706.1-2020 and its related standards, they shall be effective on May 1st, 2023.

    If the related new standards' effective date is prior to Dec 31st ,2025, there are different scenarios for product registration:

    1.      Since the effective date of new standards, for initial registration of Class II and Class III medical electrical equipment submission, all new testing reports shall meet the requirements of the new 9706 (IEC60601) standards. If having submitted application prior to the new standards' effective date and got NMPA receipt notice, manufacturers can follow the old standards to do the testing for NMPA review and approval.

    2.       For manufacturers with existing certified Class II and Class III products, testing for the registration required to meet GB 9706 standards is extended to a 3-year period.

    They need to submit new testing reports in comply with the new GB 9706 standards (IEC 60601), and complete modification registration within 3 years after the new standards' effective date.  

    If the related new standards' effective date is after Dec 31st ,2025, manufacturers with certified products shall comply with new standards' requirements and complete the modification registration before the effective date of new standards.

    The new standards require risk management documents and other materials that China testing centers are not used to couple with large volume of active medical devices that need to be compliant. It will take a long time to complete manufacturers' necessary tests.

    Testing Requirements

    The testing report can be submitted by either entrusted testing center or registrants.

    If entrusted testing centers that do not meet all the new standard testing qualifications, they may subcontract testing.

    For major issues such as basic performance and model typical description, relevant opinions shall be included in the testing report for NMPA reference.

    If you need to know details of standards, please email me. 



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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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