Import-Export of Medical Device components into the US

M

MIREGMGR

#21
Do we need to introduce an additional layer of selling to our US agent/subsidiary and then having them process each sale or is it ok to process the sales order to the distributors but identify/designate our initial importer.
My experience has been that it's common for outside-US device makers to ship directly to non-Initial-Importer US distributors, even though my understanding is that there must be an Initial Importer in the legal-title chain.

This gets into legal questions that will need to be addressed in your transaction contractural documents, so I think you'd be best served to work this out with the advice of a lawyer who is familiar with international trade.
 
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M

MMBer

#23
You do not need to register as an importer unless you are importing a functional medical device. It should be obvious to a CBP inspector that they are components and not finished devices.
 
#24
Who is the named responsible manufacturer of the device you manufacture (i.e. whose name and contact are on the label)? Is it your company or the export company you sell to?
Different company, but your answer could help. What if my company is receiving semi-finished product from an OUS parent company, we are completing final packaging, and then shipping OUS?
 
#25
Related to this discussion but another question: I understand the responsibilities of the initial importer (complaints, tracing), but if we are both the initial importer and distributor of a foreign medical device (class 1), does our address and contact information have to appear on labeling?

If we have a contract with the manufacturer in China stating that we may receive complaints and will forward to them for their tracking and investigation, does that mean that only their contact information can appear on the labeling?

From a business perspective, I believe we should have our contact information on the labeling with the qualifier of "Distributed by:" so that our customers can have a US contact point rather than a China contact point but I cannot find a requirement that a product distributed in the US must have a US contact on the labeling. Everything seems to assume this using US centric terms (city, state, zip code). I am getting pushback from marketing (long story) on having our information on the product and they are challenging me to show them the FDA requirement that shows we must.
 
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