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CFDA Manufacturer Definition

  • 1.  CFDA Manufacturer Definition

    This message was posted by a user wishing to remain anonymous
    Posted 12-Sep-2018 11:08
    This message was posted by a user wishing to remain anonymous

    Hello!
    Does anyone know how CFDA defines the term "Manufacturer"

    Does it refer to actual physical or legal responsible manufacturer?

    Do both need to be identified with CFDA, or is the legal responsible manufacturer sufficient? 

    How does CFDA define physical manufacturer?
    1. Entity that performs actual physical manufacturing?
    2. Entity that performs the finished device labeling and packaging? 

    Thank you for your help and looking forward to valuable guidance.