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  • 1.  China Medical Device UDI: First Batch Implementing October 1, 2020

    Posted 30-Jul-2020 22:55
    By October 1, 2020, the 1st group of identified device categories must be implemented with their UDI data into the China UDI data system with the qualified suppliers. 

    What the UDI Plan Says

    The "Unique Device Identification (UDI) System Implementation Plan" was published on July 7, 2019.

    Based on the plan, the unique identifier should include the Device Identification (DI) and the Production Identification (PI). DI is the unique code identifying the license holder, the model and the packaging information of the medical device; PI is composed of codes related to the production process, the serial number, batch number, production date and expiration date. The DI and related data have to be uploaded to the Medical Device Identifier Database, within 60 days after the product is approved or renewed, and before the commercialization of the product.

    Timeline

    • From October 1, 2020, the 1st group of UDI mandated medical devices i shall have unique identifiers
    • Starting October 1, 2020, for initial registrations, the applicants shall submit the identifiers of the smallest sales unit to the registration management system
    • Starting October 1, 2020, for renewal and modification on registrations, the applicants shall submit the identifiers of smallest sales unit to the registration management system
    • Starting October 1, 2020, before sales, the registrant shall upload the product identifiers and related data of the minimum sales unit and the higher-level package to the unique identification database

    Key Takeaways for Manufacturers

    • The code issuing agency shall have a certified legal entity in China with a sound management system. Currently the agencies include: Zhongguancun Industry & Information Research Institute of Two-Dimensional Code Technology, Ali Health, Mashangfangxin Platform, GS1 China, etc.
    • The unique identification report for the previous year shall be submitted by code issuing agencies to the NMPA before January 31 of each year.
    • The identifiers of smallest sales unit shall be submitted to the registration management system.
    • For devices produced since October 1, 2020, before the commercialization of the products, their identifiers shall be submitted.


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


  • 2.  RE: China Medical Device UDI: First Batch Implementing October 1, 2020

    Posted 31-Jul-2020 04:22
    Grace,

    Thank you for this information !

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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