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China GMP for standalone software will be implemented on July 1, 2020

  • 1.  China GMP for standalone software will be implemented on July 1, 2020

    Posted 18-Feb-2020 21:01

    If you know China GMP system, you might be familiar with the following guidelines:

    1. Good Manufacturing Practice for Medical Devices
    2. Good Manufacturing Practice Annex on Class III Medical Devices
    3. Good Manufacturing Practice Annex on Sterile Medical Devices
    4. Good Manufacturing Practice Annex on Implantable Medical Devices
    5. Good Manufacturing Practice Annex on In Vitro Diagnostic Reagents
    6. Good Manufacturing Practice Guidelines for Onsite Inspection
    7. Good Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical Devices
    8. Good Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical Devices
    9. Good Manufacturing Practice Guidelines for Onsite Inspection of In Vitro Diagnostic Reagents

     
    The tenth GMP came up last year. NMPA published Good Manufacturing Practice Annex on Standalone Software on July 12, 2019. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers have to meet the eight special requirements listed in the Standalone Software Annex:

    1. Personnel
    2. Equipment
    3. Design development
    4. Procurement
    5. Manufacturing management
    6. Quality management
    7. Sale and after-sale
    8. Adverse event monitoring and analyzing

    The Annex is based on Software as a Medical Device (SaMD): Application of Quality Management System, published by International Medical Device Regulators Forum (IMDRF), and international standard IEC 62304.

    NMPA also states that three already issued guidelines, Software Technical Review Guideline, Cyber Security Technical Review Guideline, and Mobile Device Technical Review Guideline can be used as references for standalone software registration.

    The Standalone Software GMP will be effective on July 1, 2020.

    For a copy of the software GMP guideline or want further info on the eight requirements listed above, please leave your comments here or email me at gpalma@ChinaMedDevice.com.

     

     



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


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