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Subject:
Re: Large nipple shields in Aust
From:
"Dana Schmidt, RN, IBCLC" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 2 Jun 2014 12:29:20 -0400
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I was importing and selling the Mamivac nipple shields (including the 28s) in the USA until the FDA requirements changed in January 2013.  I was going to be charged $2500 to be an initial importer and then had to meet requirements as a manufacturer including hiring my own independent quality assurance provider.  It became more than I could do which was very disappointing.  Mamivac could not assist us with any of the regulations as much as they tried.  I do believe someone else has taken over the USA but at a higher per product fee than I was charging.  It must be due to the fees imposed. 

Dana Schmidt, RN, IBCLC

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