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  • 1.  QMS requirements on distributors

    Posted 27-Feb-2017 11:31
    Hi all,
    I was wondering what are the regulatory requirements distributors (of medical devices) should have in their QMS.
    Assuming that a distributor is 9001 certified, what additional requirements should their QMS fulfill?

    Thank you for your valuable opinion.

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    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom
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  • 2.  RE: QMS requirements on distributors

    Posted 27-Feb-2017 12:51
    Great question Lorenzo.  The answer lies with the various markets you supply.  Some regulatory requirements are well-established in guidance documents.  For example, Singapore's HSA published document GN-01-R3  Guidance on the Application of Good Distribution Practices and also GN-06-R2.2  Guidance on Distribution Records for Medical Devices whereas Canada's agency provides a guide to recall of medical devices, GUI-0054  which would contain information you would want to include in your QMS.

    I doubt you will find one place that is going to give you an outline of what to include in your QMS, but I hope I've given you a start on where to begin looking for the information you can review for the information.  

    All the best.  Let me know if you want to engage any further.

    John Beasley, RAC (US)
    MedTech Review, LLC



    Original Message


  • 3.  RE: QMS requirements on distributors

    Posted 28-Feb-2017 11:09
    Hi Lorenzo... Distributors may provide a variety of services. Therefore Distributors QMS scope should be based of those services that are provided. E.g., Distributors may provide 3PL services, therefore Distributors should be concern with "Good Distribution Practice For Medical Devices (GDPMD). The regulatory markets will most likely dictate the requirements.

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    Ray Witherspoon
    Manager Regulatory Affairs and Quality
    ray.witherspoon@mckesson.coMemphis TN 38119
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    Original Message


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