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  • 1.  Domestic Distributor

    This message was posted by a user wishing to remain anonymous
    Posted 04-Aug-2021 17:07
    This message was posted by a user wishing to remain anonymous

    Hi Everyone,

    Does a domestic distributor(who is also a manufacturer and importer for foreign products), need to register a domestic manufacturer in the DRLM whose product they distribute?

    Also, when I say domestic, I mean USA.

    Thank you in advance.


  • 2.  RE: Domestic Distributor

    Posted 04-Aug-2021 17:47
    True U.S. wholesale distribution (as defined by FDA) is not subject to establishment registration or device listing.  Accordingly, that business operation should not (in fact, cannot to my knowledge) be added to a FURLS DRLM record.  But don't forget that this is without prejudice against the potential remaining need to register regarding certain other operations in which the firm is engaged that trigger a registration requirement in their own rights, like manufacturing, importation, complaint filing, etc.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 3.  RE: Domestic Distributor

    Posted 05-Aug-2021 09:58

    Greetings,

     

    Yes, and you will need to identify the different responsibilities/activities taken in the site. Also, including who will be responsible for complaint handling.

    Here you will find the detail of whom need to be registered and why https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

     

    Valeria

    Sent from Mail for Windows 10

     




    Original Message


  • 4.  RE: Domestic Distributor

    Posted 06-Aug-2021 05:33
    Hello Anon,

    There are no facility or establishment registration requirements for distributors in the United States.  Of course, there could be local or State requirements for business licenses.  For the US FDA, there are establishment registrations for types of companies which Valeria provided the link.  In the US, a single entity could take on multiple roles. so these would need to be identified in the FURLS systems.  If a Manufacturer is acting as a Distributor for their own products or other company products, then they would only need to register as the Manufacturer.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 5.  RE: Domestic Distributor

    This message was posted by a user wishing to remain anonymous
    Posted 06-Aug-2021 08:34
    This message was posted by a user wishing to remain anonymous

    ​You don't have to register your relationship with them, but you should verify they are properly registered.
    Original Message


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