Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Who this is for: importers, clinic and laboratory buyers and compliance staff who need to know what U.S. Customs and Border Protection (CBP) expects to see on an imported medical or laboratory device, and how that differs from FDA labeling. After reading you should be able to tell which rule requires a country name, where it must appear, and which exceptions exist.
What country of origin marking is (and is not)
Country of origin marking (also searched as country of origin labeling) is a customs requirement: a foreign-origin article, or its container, must show the country where it was made so the final buyer in the United States knows where it came from. The statute is 19 USC 1304 and CBP’s implementing rules are in 19 CFR Part 134. It is not an FDA requirement: the FDA device labeling rule, 21 CFR 801.1, asks for the name and place of business of the firm, not the country of origin. The two are separate obligations that a single device label may have to satisfy at once.
Under 19 CFR 134.1, “country of origin” means the country of manufacture, production or growth of an article of foreign origin. If further work is done in another country, that work must effect a substantial transformation for the second country to count as the country of origin.
The CBP rule: 19 USC 1304 and 19 CFR Part 134
Under 19 USC 1304(a), imported foreign-origin articles must be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article permits, to show the ultimate purchaser the country of origin. 19 CFR 134.11 applies the same duty: every article of foreign origin, or its container, must be marked in a conspicuous place. Under 19 CFR 134.1, “conspicuous” means capable of being easily seen with normal handling of the article or container, and 19 CFR 134.41 requires the marking to be legible, indelible and permanent.
Who is the ultimate purchaser?
19 CFR 134.1 defines the ultimate purchaser as generally the last person in the United States who will receive the article in the form in which it was imported. If the article is sold at retail as imported, the ultimate purchaser is the retail purchaser. If it is used in manufacturing and undergoes a substantial transformation, the manufacturer is the ultimate purchaser. For a device that a clinic or laboratory receives in its imported form, that reading points to the receiving facility, so the mark has to be visible and understandable to that buyer.
Marking methods and the country name
19 CFR 134.43(a) covers surgical instruments, dental instruments and scientific and laboratory instruments (and their parts). Listed methods include die stamping, cast-in-the-mold lettering, etching (acid or electrolytic) and engraving. Metal plates attached by welding, screws or rivets are also allowed. For goods that qualify under USMCA (in force since 1 July 2020), the same section accepts any reasonable method that is legible, conspicuous and permanent, and part 102 rules decide origin for marking purposes (see 19 CFR 134.1).
19 CFR 134.45 says the marking includes the full English name of the country of origin unless CBP authorizes another form; accepted variants exist (for example “Brasil”).
Exceptions and container marking
| Exception | What it says | Source |
|---|---|---|
| Incapable of being marked | Articles that cannot be marked are excepted from marking the article itself | 19 CFR 134.32(a); 19 USC 1304(a)(3) |
| Container shows origin | Articles for which marking the containers will reasonably indicate the origin | 19 CFR 134.32(d) |
| Purchaser must know origin | Articles for which the ultimate purchaser must necessarily know the origin by the circumstances of importation | 19 CFR 134.32(h) |
| Importer’s own use | Imported for the importer’s own use and not for sale | 19 USC 1304(a)(3) |
| Cannot be marked later except at prohibitive expense | Articles that cannot be marked after importation except at prohibitive expense | 19 USC 1304(a)(3) |
| Produced more than 20 years before importation | Excepted from marking | 19 USC 1304(a)(3) |
Under 19 USC 1304(b), where an article is excepted, its immediate container generally must be marked. The exceptions above are a selection; the full list is in 19 CFR 134.32 and 19 USC 1304(a)(3). Consult the complete texts, or a customs broker, before relying on one.
FDA labeling is separate
21 CFR 801.1 requires a device label to specify conspicuously the name and place of business of the manufacturer, packer or distributor. If the named firm did not make the device, the label must show that relationship, for example “Manufactured for” or “Distributed by”. The place is the street address, city, State and ZIP code (the street may be omitted if the firm is listed in a current directory). 21 CFR 801.1 contains no country-of-origin requirement. Related reading on the FDA roles is in private label vs white label vs OEM in medical products and FDA-registered establishment.
Common mistakes
- Treating the manufacturer’s address on an FDA-style label as the origin mark. 19 CFR 134 asks for the country of origin, in English, in a conspicuous place.
- Marking only the outer carton when the exception for an article does not apply. Under 19 USC 1304, the article is marked unless an exception applies, and the container is marked when one does.
- Using a mark that is not permanent, such as a loose label on an instrument for which 19 CFR 134.43 lists die stamping, etching or engraving.
- Removing or covering a required mark. 19 USC 1304(l) sets a fine of up to $100,000, up to one year of imprisonment, or both, on a first violation for defacing or removing a mark with intent to conceal the origin.
- Mixing up marking with government-purchasing origin rules. Those are a different regime; see Trade Agreements Act compliance. For how shipping terms fit in, see Incoterms.
FAQ
Is country of origin marking the same as country of origin labeling?
In customs law the requirement is called marking: 19 USC 1304 and 19 CFR Part 134 govern the marking of imported articles. People searching for “labeling” usually mean this same CBP duty, and it should not be confused with FDA device labeling under 21 CFR Part 801.
Does the FDA require “Made in” on a medical device?
21 CFR 801.1 requires the name and place of business of the manufacturer, packer or distributor, but it contains no country-of-origin requirement. The origin mark comes from CBP rules.
Sources
- 19 CFR 134.1, 134.32 and 134.43, Cornell Legal Information Institute, checked 2026-10-31: law.cornell.edu/cfr/text/19/134.1, 134.32, 134.43.
- 19 CFR Part 134 (sections 134.11, 134.41, 134.45), eCFR, checked 2026-10-31: ecfr.gov/current/title-19/part-134.
- 19 USC 1304, Cornell Legal Information Institute, checked 2026-10-31: law.cornell.edu/uscode/text/19/1304.
- 21 CFR 801.1, Cornell Legal Information Institute, checked 2026-10-31: law.cornell.edu/cfr/text/21/801.1.
