What information do i need to get from the device manufacturer

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rudra

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We import medical devices from outside the US serving as the importer/distributor and i am developing a document/checklist to ensure that all the requirement information/details/ material we need from the non-us manufacturers are gathered when we import. can i get help/suggestions on what are the most important informations/materials we secure from the manufacturer so that we can be compliant with FDA .
 
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