Regulatory Open Forum

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  • 1.  Change product name

    Posted 21-Jul-2016 20:46

    Dear all,

    I would like to know the process of changing IVD product name (trade name) in US, CE marking countries and China.  Changing product name from A to B is a new submission/registration process in Japan.  I would like to ask your help for information of the process in other countries.

    Best regards,

    Toru

    ------------------------------
    Toru Murakumo RAC
    General Manager, Regulatory Affairs
    LSI Medience Corporation
    Tokyo, Japan
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  • 2.  RE: Change product name

    Posted 23-Jul-2016 11:04
    Toru,

    US
    - Updating registration and listing information would be required as required under 21 CFR Part 807 (especially under section 26 and 28).

    EU
    - Updating CE Mark Certificate would be required by notifying the NB.

    China
    - Declaration of Change would be needed to submit. 
    You may refer to China's new medical device regulations at Medical Device Regulations in China

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message


  • 3.  RE: Change product name

    Posted 03-Aug-2016 08:03

    Dear David,

    Thank you very much.  Sorry for my late response.

    Kind regards,

    toru

    ------------------------------
    Toru Murakumo RAC
    General Manager, Regulatory Affairs
    LSI Medience Corporation
    Tokyo
    Japan

    Original Message