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April 2011
In this issue:
 FDA
Import Entry Review Process
When an imported product arrives in the US, certain information must be
provided/transmitted electronically to the United States Customs and Border
Protection (CBP). When the product is or may be regulated by FDA, CBP sends the
import entry information to FDA for verification to ensure that the product
meets FDA requirements. Without the proper information, FDA may initiate a
manual review of each line of your entry, which may lead to delays in its
release to the importer/consignee.
FDA recently issued a letter to device companies
regarding concerns with some device types such as eyeglasses
and electrode leads, that in their experience often do not have sufficient entry data
for CBP. Even if you do not produce these particular products
for the US market, it is important to be aware of the US
entry process to avoid delays. If we are your United States Agent, don't
worry - we will
provide you with all the necessary information to include on
your invoice for your shipment. Let us know if you have
any questions.
To access the full letter from FDA, click
here.
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