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  • 1.  Change in Legal Manufacurer

    Posted 24-Jun-2021 01:56
    When there is a change is Legal Manufacturer (location change), what is the typical impact? What needs to be updated from the perspective of Documentation, Registration & Certifications? Certification or FDA Approval to the products? Can anyone help please.

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    Anirban Banerjee
    Bangalore
    India
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  • 2.  RE: Change in Legal Manufacurer

    Posted 24-Jun-2021 07:51
    Hi Anirban

    Can you clarify which jurisdiction? And is this for devices or drugs?

    Is this US only? For example, for the US, nothing will change as far as how devices were cleared. That is something that happened in the past.

    All documents that contain the address of the manufacturer will have to be updated.

    Any certificates, such as MDSAP need to be reviewed to see if a  new audit is required or if the address change is merely administrative.

    The address change needs to be reported to FDA using the FURLS establishment and registration system.

    Fur Europe and other jurisdictions, you will need to interact with the Notified Body, local representative and or authority responsible for registrat9ion.

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    Jean Bigoney PhD, RAC, CQE
    Senior Regulatory Affairs Specialist
    Morrisville NC
    United States
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    Original Message


  • 3.  RE: Change in Legal Manufacurer

    Posted 25-Jun-2021 09:52
    Changing your registration with the FDA and Health Canada is relatively straight forward.  Getting revised certificates from your Notified Body will take a considerable amount of time.  Depending on other countries where you have a product license, it can be as easy as a license amendment or as difficult as basically starting all over again.

    The big issue is the labeling.  You need to build up inventory of product as any device built in the new location must be labeled with the new address and supported by your new certificates.  In Canada, once you change your registration, no product with the old address can be sold into Canada.


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    Al Van Houdt RAC
    Sr. Mgr. Regulatory Affairs & Compliance
    Snoqualmie WA
    United States
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    Original Message


  • 4.  RE: Change in Legal Manufacurer

    Posted 30-Jun-2021 16:24
    I agree - it depends on the region where you sell your device. In Russia you have to change the license and register under a new LM.

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    Oksana Kolosova
    Moscow
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    Original Message


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