Aaryak Joshi At the site where the finished product is packaged to be supplied from and from where the package/label is not changed in anyway unless to be used by the end user, should be the site of origin. so if after final packaging in UK, there are no changes made to the package or label when it lands in US until it is opened by the customer for final use, then I believe, UK should be the origin, based on my personal opinion, I do request you and group members to validate it from valid sources because I too am making assumptions while presenting this info, other aspects may change this. Hope it helps you get started, I would only suggest that interpretation of allied attributes should also be carefully made as they may get confusing.

Thanks Aaryak. I think my information gap is in knowing which FDA Medical Device and / or any other US commercial regulations apply to a Country of Origin claim.

Sabine Nieba In the US, Country of Origin ("Made in") is required for Import by the Bureau of Customs and Border Protection (CBP), refer to 19 U.S. Code § 1304 - Marking of imported articles and Containers.

Does anyone know if a similar requirement to identify the 'country of origin' (made in) applies on CE marked products?

Maria - EEA regulations are in the medical device directive and related documents; CE marked products must be marked with the Legal Manufacturer's name and address.

Sabine - I have read 19 U.S. Code § 1304 but cannot find out where the rules used to identify / decide "country of origin" are. Do you know?

Aaryak Joshi Hi Mike, the regulation mentioned by Sabine is also known as 19 CFR 134, so if we refer to 19 CFR 134.1 - General Provisions (definitions), it defines Country of origin as follows: (b) Country of origin. ‘‘Country of origin’’ means the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the ‘‘country of origin’’ within the meaning of this part; however, for a good of a NAFTA country, the NAFTA Marking Rules will determine the country of origin.

This definition is largely dependent on interpretation to understand what processes may be considered significant enough to make a substantial change to the integrity of the product, package or label, at the time when it reaches the end user, as it was approved/cleared by the regulators, in the first place.

so to ensure compliance, I believe following these simple parameters help, in general:
* we identify the country where the finished product is manufactured/packaged, to be shipped

* identify all the processes in between the shipping of finished product up until it reaches the end user

* cross check if any of these processes are considered significant by the process, product, country relevant regulations. (reviewing relevant guidance(s) and such)

* if they are then that place of business will be COO (ex. an importer repackaging/relabeling or such........ but that too differ in case of type of importer sometime, say a healthcare facility's internal pharmacy as the direct importer may have different regulations)

* if not the last shipping site, (place of Business of Manufacturer), will be the COO if these are two different countries.

More than the marking requirements, this information is required at multiple places in various applications/documents to the FDA, so that also should be consistent...

Below is the link to the definition I was referring earlier...I would highly request you to not consider this as a professional advice and do validate before considering...Hope it helps...

Best
Aj

http://www.gpo.gov/fdsys/search/pagedetails.action;jsessionid=STyNVnvXZfT2vTbYbpqQ0sNWRTVd2Gh9vKz7dfcchyqKSPcSpR7G!1775773358!1934295254?collectionCode=CFR&searchPath=Title+19%2FChapter+I%2FPart+134%2FSubpart+A&granuleId=CFR-2011-title19-vol1-sec134-11&packageId=CFR-2011-title19-vol1&oldPath=Title+19%2FChapter+I%2FPart+134%2FSubpart+B&fromPageDetails=true&collapse=true&ycord=1463

Aarayk - thanks for the pointer to 19.cfr.134. While the terminology found in 134.1(a) is reasonable, it is generic. What experience is out there in using the OBL = Legal Manufacturer country as CoO when the OEM is in a different country? This must be a common occurrence, so which CoO do companies choose in such circumstances?

Marcia Kilby Sterilization does not confer origin, nor does the location of the actual manufacturer. Origin will be conferred by the location providing substantial transformation, which I suspect is Germany in this scenario.

Marciano - I understand your logic, but the European regulation, and especially that of Legal Manufacturer take a fundamentally different approach, in order to establish and ensure accountability and traceability. In that context, do you know what the FDA or US view on this scenario, can one follow the EU logic in declaring CoO for US purposes? This must sur lay be a well-trodden path? Mike

Aaryak Joshi To add to that Mike, the US customs and FDA have separate definitions for origin, they do converge at times and they do diverge at times. But both need to be complied by for import. Check this OASIS system on FDA's website they have given some examples there, you may have to do a keyword search on FDA website with "OASIS" to review different training modules, on it aspects.

Sabine Nieba I agree with Marcia. The country where the legal manufacturer (who is responsible for the product) resides and the Country of Origin (where substantial transformation of the product was carried out) are not identical in your case. Be also aware of the US FDA requirements for listing of contract manufacturer's (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm318796.htm#changes) which might apply to the German company.

Charles Grato Mike - Sorry late to this party...

You stated that it is a Combination Product of an OEM in Germany. With Medical devices, Combination Products have a few different meanings; I am going to assume that this combination product is a single device that has two or more medical uses and is packaged as single device. (The client should also be aware of importing a combination product the US. but that's a separate issue that has to do with medical device approvals)

Back to the issue at hand

For the purposes of covering ONLY the question of "Country of Origin Labeling” of an imported Medical Device into the USA for both US Customs and the FDA.

The Country of Origin for labeling purposes is still where the device was Manufactured/Assembled based on the Rules of Origin in 19CFR134.11.
(http://www.ecfr.gov/cgi-bin/text-idx?SID=3000d448aa0362bf5e38d8aa442bf80f&node=19:1.0.1.1.28&rgn=div5#se19.1.134_111)

But for Country of origin Labeling of a medical device imported into the US,

The Legal Manufacturer and the Country of Origin are two separate issues and both need to be addressed and shown.

All of this can be found in 21CFR section 801. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=801.1)

The FDA requires all products to be labeled with the Legal Manufacturer’s Name and Address, the legal manufacturer is the entity that has registered the device with the FDA (this does not state that its origin is where the legal manufacturer is, unless it actually is the same facility, then yes it does)

The Address of the manufacturer/assembler and the actual country in which the product is actually manufactured/assembled. (Suggestion; depending on label real-estate/space, leave a space between the legal manufacturer's address and the country of origin. Or put them side by side being sure to indicate which is which.

I hope this helps...

Charles Grato Also in addition. the origin is not determined where the device is finished. this goes to the issue where US Customs and the FDA come together in one issue, but are total opposites on other issues.

as an example. The FDA does not technically consider an unsterilized device a finished device. the FDA considers the sterilization process, a process of manufacturing, and usually the finishing process.

US Customs on the other hand DOES NOT consider sterilization a manufacturing process. Customs takes the position that the device; when it enters the sterilizer is almost 99% of the time completed and packaged for sale. It is a process of circumstance.

If you need any help that I may be able to provide, inbox me. I have spent my share of time at one of the largest Medical Device manufacturing companies in the world. if I don't know the answer I can make a call and get an answer.

Robert Poyser Lets add a bit more confusion....if the materials for the products that were made in Germany, were manufactured in different countries and mined in others, does this mean your problem has now grown.... NO.

I would interpret country of origin is the country where the product became "a product".
Where its packed or labelled is immaterial for the US's "County of origin".
The problem is "does sterilisation finalise the product" into being... I would say no (but that could be agued, I suppose), therefore there is a strong augment that your produce of origin in this case is Germany.

Note: "County of origin" and "legal manufacture" are not the same thing.
"Country of origin" does not put any form of accountability for a product (each country in the world has good and bad manufactures, so origin is really immaterial but "not Made in the US" is relevant).

Now "Legal manufacture" focuses accountability and responsibility!
And in my mind of high relevance.

Here a good PDF that may help you clarify
https://www.donaldson.com/en/supplier/compliance/origin.pdf

Thanks Robert - the referenced pdf ids most useful