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Minimum FDA Requirements for Distributors

Discussion in 'US Medical Device Regulations' started by ARNEL MONTERO, Mar 23, 2016.

  1. ARNEL MONTERO

    ARNEL MONTERO New Member

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    Hello Guys,

    What are the minimum requirements set by the FDA or a company should have to comply with the regulations if the company is a medical device distributor?

    Like, should the company has QS policies and the like, SOPs, or should they secure a complete list of products with their regulatory information. Any help is pretty much appreciated. Thank you!
     
    ARNEL MONTERO, Mar 23, 2016
    #1
  2. Ronen E

    Ronen E Well-Known Member

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    Hi,

    It's almost impossible to answer this question fully and correctly. The answer could range from "almost nothing" to some substantial requirements - depending on the specifics.
     
    Ronen E, Mar 23, 2016
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  3. Zara Joyce

    Zara Joyce Member

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    I think you should check the FDA website for details about these things. They usually have detailed information about the rules and regulations that applies on the Medical industry related business.
     
    Zara Joyce, May 5, 2017
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