Exporting then re-Importing 510(k) device

S

SuperGirl

#1
Okay, so I've tried to find this topic, and haven't had any luck, but if it's out there I'm sorry. It could be that I just don't know where to look exactly, and that I'm having a difficult time rapping my head around this.

The company that I work for, is trying to see if the logistics of this project could work, before jumping in. Something very new. What we are doing is obtaining Alcohol Pads and Gloves (both 510(k)) products from a domestic (US) source, then exporting those to China, where they will be added into a pack with cots sheet and a blanket, then they completed pack will be sent back to the US, where we will sell them.

My question is what information is required for us to have, as far as the FDA is concerned, to re-import these.

Currently we don't have the 510(k) number for either of the products, because we are just a distributor for them.

Any help would be greatly appricaited. :thanx:
 
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M

MIREGMGR

#2
Is the offshore company a registered device establishment?

If yes, will they be the Kit Packer, or will they be a contract manufacturer with you remaining responsible for the kit packing?

If you're the responsible Kit Packer and they're a contract manufacturer, it doesn't matter where they are...their output is components, which become devices upon your receipt and final processing of them.

Note that in the latter case, the label probably still will carry the Made in China designation per Department of Commerce rules, which ignore FDA responsibility concepts and just consider value percentages. But, the FDA label designation for the Manufacturer will be you, at your US address.
 
S

SuperGirl

#3
Yes, they are/ will be registered as the Kit Packer, but that's not really the quesion. Lets see if I can be more specific. What I can't seem to figure out is how to get the 510(k) componets back into the states. We are a distributor for a company that has that will be supplying two componets (both require a 510(k)) We will be sending those to China, the manufacture will complete the rest of the packs and assemble them and ship them back to us. For items we are the initial importer on that require a 510(k), we have that information, and submitt that to our Customs Agent that handled all asspect of entry for us. Do we need that information form the origial US company, that doesn't necissarliy know that we are sending them to back to China. (The company that we get them from is a US company, that has the products made in China). I think that may have help, or I may have just completely confussed myself and everyone.
 
M

MIREGMGR

#4
You may be an Initial Importer if the imported materials are medical devices per FDA definition. You definitely are not an Initial Importer if the imported materials are components, rather than medical devices.

If the Chinese kit-assembly company was a contract manufacturer and you were the Kit Packer, then you would not be an Initial Importer. In that case, the fact that the actual kitting work was done offshore would be irrelevant. You as the Kit Packer would maintain the appropriate DMR for your kits, in conjunction with the makers of the kitted devices. Assuming that there were no stop-importation orders involved and no other restrictions, and the products' labeling correctly identified the country of origin for duty purposes, Customs would not have a reason to be specially involved.

If however the Chinese kit-assembly company is a registered Device Establishment and will be the Kit Packer, and you will be only a distributor of their kits, then the status of the 510(k)s is not your regulatory problem...it's theirs. It's up to them to have an appropriate DMR for their kits, particularly including regulatory information from the makers of the kitted devices, to provide to you as the Initial Importer.

We import about a container a week of mixed components, FDA Class I and II devices, and device kits, mostly from an FDA-registered Chinese company with which we have an arm's-length relationship, so we have a fair amount of experience in somewhat similar circumstances.
 
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