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  • 1.  China legal agent

    Posted 04-Jul-2021 00:28

    Hi,

     

    Does anyone have an idea whether its possible to have more than one legal agent for China.

     

     

    Thanks & Regards,

    signature_1537400070

    Rashmi Pillay

    Regulatory Affairs Manager

    Ellex – Lumibird Medical group

    3-4 Second Ave, Mawson Lakes SA 5095
    Tel. +61 8 7074 8105

    Email rpillay@ellex.com

     

     

     

     

     

     

     

     

     

     

     

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  • 2.  RE: China legal agent

    Posted 05-Jul-2021 00:43
    Hello,

    I suppose legal agent here means the authorized representative in China. 

    I am not sure about the latest regulation, but, I believe the authorized representative is limited to one for one category of product. Thus, you can appoint the second authorized representative for the other category of product. 
    I don't have time to check the regulation now, thus, I am answering only from my memory (so forgive me if it is wrong), but I suppose you can find the description about it in the regulation and the other member might give you a better advice!

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    Soichiro Iida
    Kyoto
    Japan
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    Original Message


  • 3.  RE: China legal agent

    Posted 05-Jul-2021 02:56
    Edited by Hamish King 05-Jul-2021 02:57
    Rashmi

    Soichiro is quite right - NMPA Legal Agent is the interface with NMPA and is limited to one per product. However, your company may elect to have a different NMPA Legal Agent for different products, so per manufacturer you might have more than one.

    Regards
    Hamish

    ------------------------------
    Hamish King
    Cisema
    www.cisema.com
    hamish.king@cisema.com
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    Original Message


  • 4.  RE: China legal agent

    Posted 06-Jul-2021 14:46
    NMPA legal agent name appears in each of the NMPA product certificate.  Each product certificate must have a registration company name and address (MAH/overseas manufacturer) as well as the legal agent name and address.  The legal agent must be a business registered in China.  If the overseas manufacturer has an office in China, that office can be the legal agent.  If not, the manufacturer can appoint a local legal agent.  When we perform registration, we often take on legal agent roles as well for those overseas manufacturers without local offices.  The new State Order 739 stipulates more the roles and responsibilities of the registration company (manufacturer) for the complete product life cycle.  The roles and responsibilities of the legal agent is elaborated in the follow-on supporting guidance Medical Device Registration Administration Measures (draft). Below is a comparison of the key updated areas in Order 739 vs the old 860.  As you can see, the biggest jump in the incremental articles are in the legal responsibilities.   
    I do have a copy of the English version of Order 739.  If you are interested in a copy, please send me an email gpalma@ChinaMedDevice.com   I will be happy to share with you and learn your experience in interpreting it. 



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

    Original Message


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