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  • 1.  Legal manufacturer

    Posted 06-Mar-2018 06:18

    Hi,


    QMS certificates are issued to the legal(primary) manufacturer/manufcturing address . What does legal here imply?Does it primarily mean the address that is responsible for handling complaints or does it also include an address which is a  registered office  ( legal perspective)?


    regards,


    Rashmi



  • 2.  RE: Legal manufacturer

    Posted 07-Mar-2018 07:51
    Hello Rashmi

    The legal manufacturer is the one whose name and address is on the product label. Ultimately the legal manufacturer has the legal liability re: injuries, disposal, etc.


    Best regards,

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com



    Original Message


  • 3.  RE: Legal manufacturer

    Posted 09-Mar-2018 07:25
    Some regulations gave definitions for legal manufacturer, most don't. But usually the legal manufacturer is the the one responsible for the "registration" of the product on its country of origin (and formally recognized as such by the country of origin regulatory authority).

    ------------------------------
    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
    ------------------------------

    Original Message


  • 4.  RE: Legal manufacturer

    Posted 09-Mar-2018 07:44
    Legal Manufacturer (LM) means entity responsible placing the product on the market irrespective of product is being manufactured at their own facility or using OEM facility, responsibility also lies with LM in respect of quality, safety, performance, PMS handling etc.,  

    further, it is important to interpretate definition of LM with the country specific regulation.

    thank you!

    ------------------------------
    Saurabh Kumar Sharma
    Manager-Regulatory Affairs
    India
    ------------------------------

    Original Message


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