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  • 1.  Vendor Qualification

    Posted 18-Oct-2018 16:55
    Hello,

    What would comprise of substantial evidence to qualify medical device distributors? Do they need to be ISO 13485 or 9001 certified? Are there any additional requirements that need to be fulfilled?

    I would really appreciate any help!

    Thank you,


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    Manasi Mahajan
    RA/QA Engineer
    Burbank CA
    United States
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  • 2.  RE: Vendor Qualification

    Posted 19-Oct-2018 03:00
    Hi Manasi

    No, they do not need to be certified - but it makes things easier. You need to make a contract for them to sign where the agree to the terms you need for your own system: Informing you in case of incidents, change in regulatory demands in their area etc. It is your responsibility to evaluate the vendors and keep them in accordance with the written agreement - certification or not. 

    Best regards

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    Dorthe Wallin
    Regulatory Compliance Officer
    Cortex Technology
    Hadsund
    Denmark
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    Original Message


  • 3.  RE: Vendor Qualification

    Posted 19-Oct-2018 05:04
    As mentioned, there is no need that distributors have ISO certification, but it greatly helps.  In some situations having ISO certification provides another layer of checks on the QMS at least showing that a QMS has been implemented - although do not always take ISO certification at face value.  If you have a significant distributor and they are repackaging/relabeling product for you this may warrant you conducting an audit of their operations and facility as well.

    A distributor agreement or contract is strongly recommended and not just no containing those business jargon, but also includes all regulatory and/or quality requirements as well.  With the publication of the Medical Device Regulation (EU) 2017/745 there is much more demand on distributors what is expected for compliance.  This is especially true if your distributors are handling customer complaints initially or they are responsible for all of the customer interaction.

    To answer your last question, there may be a lot that a distributor has to fulfil.  This depends on the country they are in (local regulatory requirements), what they are doing for you such as repackaging, what their customer interface is in relation to who is using the device, etc.  In the medical device world, gone is the day when a distributor "just sold product."  Medical device manufacturers need to keep aware of the entire product life cycle for their products.

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    Richard Vincins RAC
    Vice President Global Regulatory Affair
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    Original Message


  • 4.  RE: Vendor Qualification

    Posted 19-Oct-2018 08:44
    Edited by Michael Winter 19-Oct-2018 08:43
    ​If you are referring to a domestic distributor that is furthering your device within the USA, I don't know of any requirement for an agreement.  The distributor has requirements, but I don't believe that those are specifically bound to you.  The manufacturer has to "maintain records of the name and address of the initial consignee."  Your distributor would be the initial consignee.  If the device is going outside the USA, then there are requirements for licensing and distribution that would need to be written.

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    Michael Winter RAC
    Curbell Medical
    Sr. Director, Quality and Regulatory Affairs
    Alden NY
    United States
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    Original Message


  • 5.  RE: Vendor Qualification

    Posted 20-Oct-2018 08:19
    Hello there,

    If they are distributing in the US, they certainly could need annual state licenses to distribute the product (many states require thus). Also, your organization  under QSR or ISO 13485 are expected to assure your product is handled and stored appropriately to assure its quality and efficacy, and traceability to end user.  

    I would send your distributor a screening audit questionnaire and certainly recommend you consider detailed questions on how they trace, store, handle, train, etc. Consider them a  "Supplier" , as they are supplying services.  TUV SUD emphasized this recently in a client certification audit, and thankfully they had. 

    I also recommend a Distributor Quality Agreement or putting quality items in your contract, if you do not put them in a Q Agreement. Specify what you will do versus what they will or can do regarding complaints, recalls, quality issues,  etc.. Under what if any conditions  do they handle and classify returned product, and  can they rework it with your direction? Also, are they acting as a sales arm or training your customer? Better be sure what they are saying or doing!

    Many other countries (besides Europe) require distributors to be licensed to meet relevant Good Distribution Practices.

    Good luck setting these relationships us, they can be tricky.

    Best regards,





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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 6.  RE: Vendor Qualification

    Posted 22-Oct-2018 14:16
    Thank you all. Your feedback was very helpful!

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    Manasi Mahajan
    RA/QA Engineer
    Burbank CA
    United States
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    Original Message


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