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Is "Made in (Country)" a labelling requirement?

Mark Meer

Trusted Information Resource
#1
Just wondering if anyone can point to any medical device regulation that requires a label to state "Made in [Country]"?

Presently, our labelling includes this text, but I'd like to remove it if possible to avoid having to translate the English text.

My justification is that we already use the Manufacturer ISO 7000 symbol with our address (that includes the country), so a "Made in [Country]" text seems redundant.

Seems logical to me....but I want to double check that I'm not missing some regulation that explicitly calls for the "Made in [Country]" text on labelling.
 
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Al Rosen

Staff member
Super Moderator
#2
Just wondering if anyone can point to any medical device regulation that requires a label to state "Made in [Country]"?

Presently, our labelling includes this text, but I'd like to remove it if possible to avoid having to translate the English text.

My justification is that we already use the Manufacturer ISO 7000 symbol with our address (that includes the country), so a "Made in [Country]" text seems redundant.

Seems logical to me....but I want to double check that I'm not missing some regulation that explicitly calls for the "Made in [Country]" text on labelling.

The made in "Country of Origin" laws are usually governed by the laws of the importing country, not the medical device regulations.
 

Mark Meer

Trusted Information Resource
#3
Thanks Al. For the most part these appear to be largely focused on food and animal products. Are you aware of any such laws that may apply to medical devices being imported?
 

Mark Meer

Trusted Information Resource
#4
Now that I've been tuned into the "Country of Origin" (COO) term, I did an Elsmar search an found that this topic has been discussed previously. Here are some of the previous discussion threads:


From what I'm gathering from these (they are all more than 5 years old):
1. An example of laws requiring country of origin is 19 CFR 134
2. It is possible to have a different country of origin and manufacturer address (so my justification appears invalid).

If this is the case, could some other medical device manufacturers that ship internationally kindly advise how they overcome the translation issue? Do you maintain separate labels for each region simply to translate the "Made in XXXX" statement??
 

Mark Meer

Trusted Information Resource
#6
Thanks Al, appreciate the link. ...but is appears to be broken (but does bring you to the export.gov website). I did a search there for both "COO" and "Country of Origin", and couldn't find anything dealing with a "Made in XXXX" requirement on labels. The relevant hits had to do with certificates of origin, and commercial invoices.

Was there a specific page on the website you were meaning to link to?

Again: I'm curious how other organizations deal with this, and the translation difficulties this would entail. Any feedback/advice much appreciated...
 

craiglab

Involved In Discussions
#7
See Requirements for country of origin marking on goods imported into the U.S..

Surgical instruments, for example, have specific marking requirements:

19 CFR 134.43 Methods of marking specific articles.
(a)Marking previously required by certain provisions of the Tariff Act of 1930. Except for goods of a NAFTA country, articles of a class or kind listed below shall be marked legibly and conspicuously by die stamping, cast-in-the-mold lettering, etching (acid or electrolytic), engraving, or by means of metal plates which bear the prescribed marking and which are securely attached to the article in a conspicuousplace by welding, screws, or rivets: knives, forks, steels, cleavers, clippers, shears, scissors, safety razors, blades for safety razors, surgical instruments, dental instruments, scientific and laboratory instruments, pliers, pincers, nippers and hinged hand tools for holding and splicing wire, vacuum containers, and parts of the above articles. Goods of aNAFTA country shall be marked by any reasonable method which is legible, conspicuous and permanent as otherwise provided in this part.

Also consider the Trade Agreements Act if selling to GSA. This will explain it:
The Trade Agreements Act and Sales of Medical Devices to the U.S. Government – The Beat @ Cooley Health
 

craiglab

Involved In Discussions
#8
See Requirements for country of origin marking on goods imported into the U.S..

Surgical instruments, for example, have specific marking requirements:

19 CFR 134.43 Methods of marking specific articles.
(a)Marking previously required by certain provisions of the Tariff Act of 1930. Except for goods of a NAFTA country, articles of a class or kind listed below shall be marked legibly and conspicuously by die stamping, cast-in-the-mold lettering, etching (acid or electrolytic), engraving, or by means of metal plates which bear the prescribed marking and which are securely attached to the article in a conspicuousplace by welding, screws, or rivets: knives, forks, steels, cleavers, clippers, shears, scissors, safety razors, blades for safety razors, surgical instruments, dental instruments, scientific and laboratory instruments, pliers, pincers, nippers and hinged hand tools for holding and splicing wire, vacuum containers, and parts of the above articles. Goods of aNAFTA country shall be marked by any reasonable method which is legible, conspicuous and permanent as otherwise provided in this part.

Also consider the Trade Agreements Act if selling to GSA. This will explain it:
The Trade Agreements Act and Sales of Medical Devices to the U.S. Government – The Beat @ Cooley Health
 

Mark Meer

Trusted Information Resource
#9
...
19 CFR 134.43 Methods of marking specific articles.
(a)Marking previously required by certain provisions of the Tariff Act of 1930. Except for goods of a NAFTA country, articles of a class or kind listed below shall be marked legibly and conspicuously by die stamping, cast-in-the-mold lettering, etching (acid or electrolytic), engraving, or by means of metal plates which bear the prescribed marking and which are securely attached to the article in a conspicuousplace by welding, screws, or rivets: knives, forks, steels, cleavers, clippers, shears, scissors, safety razors, blades for safety razors, surgical instruments, dental instruments, scientific and laboratory instruments, pliers, pincers, nippers and hinged hand tools for holding and splicing wire, vacuum containers, and parts of the above articles. Goods of aNAFTA country shall be marked by any reasonable method which is legible, conspicuous and permanent as otherwise provided in this part...
Geez! :whip:

I'll have to check my forks, razors, and scissors, but I'm pretty certain that they are NOT marked this way despite, in all likelihood, being manufactured in Asia or Europe somewhere.

I'd be curious how strongly this is enforced....
 
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