Use of Made in XXX Country on Medical Device Labels

sreenu927

Quite Involved in Discussions
#1
Hi,
When do we use the sentence, "Made in [Country of Origin/OEM Supplier]" on the medical device labels?

Excerpt from ASEAN Medical Device Directive draft is as follows:

Please note that "manufactured/made in Country X" or other similar wording
can only be printed on the labels if there is significant processing of the products in Country X.
The following are excluded: simple operations consisting of removal of dust, sifting or screening, sorting, classifying, matching (including the making up of sets of articles), washing, painting, cutting up; changes of packing and breaking up and assembly of consignments; simple placing in bottles, flasks, bags, cases, boxes, fixing on cards or boards, and all other simple packing operations; the affixing of marks, labels or other like distinguishing signs on products or their packaging; etc.


Any thoughts, whether it is a legal or trade compliance or customer requirement to have this statement on the label?

Thanks,
Sreenu
 
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A

Alexisss

#2
Good morning!

Customs codes require that where "made in XXXX" is printed, XXXX will refer to the country where the largest % of the product's added value is contributed.

For example, you have a shirt which is bought from China for 4$ and you iron it in Italy, a process that adds 1$ to its value, leading to a final cost of 5$, you cannot print "made in Italy" on its label - must be "made in China".

The reason behind that is to help the customs define what duty will be added (and also related to tariffs/quotas). Because if the duty for shirts from China is 30% and the duty for shirts from Vietnam is 10%, then someone would easily print "made in Vietnam" and send them from China.

The "made in XXX" is depending on the "certificate of origin" without which you cannot import a product in certain (most) countries.
 
D

Dudes

#3
Some countries have even stringer regulations. For example, you need 50% of your product being manufactured... in Switzerland to be allowed to apply Swiss Made.
 
M

MIREGMGR

#4
"Made In XXX" is known as a Country of Origin statement.

Many countries' Customs and Border Protection services require that products coming into that country be labeled with a Country of Origin statement. Different countries have their own legal definitions, which can be very complicated. The general rule for products imported into USA is that the country of origin is the location of "last substantial transformation", referring to a physical rather than legal transformation. However, underlying this rule is a major body of law, precedents and interpretations, plus an extensive system for obtaining rulings. Treaties and trade agreements can overrule these laws, or more commonly complicate their application; the most obvious example of this is NAFTA, affecting trade between USA, Mexico and Canada.

A further complication is that US FDA also uses the term Country of Origin in their PREDICT border inspection system, but FDA defines the term differently to refer to the location at which the object is legally transformed into a medical device, whether physical transformation occurs at that location or not. Thus a product may have differing US CBP and US FDA Countries of Origin.
 
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