Regulatory Open Forum

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  • 1.  Amazon

    Posted 31-Jan-2022 19:31
    Hello,

    Does anyone have any tips for how to manage Amazon as a distributor for devices that are legally sold on their platform? I am looking for guidance on what to write in the SOP for handling a recall involving products sold through Amazon? Also, Amazon is not willing to sign any kind of distribution agreement or quality agreement. How would you document that in the QMS?

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    Erica Livingston
    Carlsbad CA
    United States
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  • 2.  RE: Amazon

    Posted 31-Jan-2022 20:23
    Hi Erica

    When a large manufacturer is working with a small supplier, it's possible for the manufacturer to impose requirements on the supplier, or for the two to work together to ensure the needs can be met.

    When a small manufacturer is working with a large supplier, the approach often has to be different. I'd start by writing down the manufacturer's requirements for that type of service provider, and then compare that to the supplier's terms of service.

    If working with them means your basic requirements can't be met, you'll decide not to work with them. If they can meet your "must have" requirements, but not your "nice to haves", you can decide if the relationship would be valuable overall. Maybe there are certain responsibilities you'd prefer to assign to them, but you decide to manage those responsibilities yourself. Then your SOP can describe what you're actually planning to do.

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    Anne LeBlanc
    United States
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