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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!
     
  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.
     
  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.
     

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