Regulatory Open Forum

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  • 1.  Listing of products not for clinical use but only for cadavers

    Posted 29 days ago

    Dear Raps Community,

    I am writing regarding query on products that are not for clinical use but only used on cadavers, do we have to do device listing of such products on GUDID or on other platform to avoid hold during product import in U.S.

    looking forward for valuable input.

    Best,

    Rabel Talpur



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    Rabel Talpur
    Pro Med Instruments GmbH
    Freiburg
    Germany
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  • 2.  RE: Listing of products not for clinical use but only for cadavers

    Posted 25 days ago

    Hello Rabel

    It may make a difference if these devices will be part of a premarket clinical study, or if they are going to an international trade show, or if they are sold for use by a specimen processing lab. In general, unusual imports can get through the border inspections if they have a clearly written identification of their purpose.

    This thread may be helpful:  https://connect.raps.org/discussion/looking-for-us-importation-advice-on-medical-device-component



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Listing of products not for clinical use but only for cadavers

    Posted 25 days ago

    For deliveries to the USA, packages were labelled "Not for clinical use. Testing only" when we had products that had to be used in V&V studies. No issues occurred at that time.  



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerlandsgrassmann@medtechxperts.com
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    Original Message


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