Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling)

C

curiousone

#1
As a Class I medical device manufacturer, do we need to place the country of origin on the retail packaging insert even if the country of origin is on the device label and the import shipping carton? Please advise.:thanx:
 
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M

MIREGMGR

#2
Re: Country of Origin Marking on Retail Packaging

The fundamental requirement, as stated at 19CFR 134.3, is that the "article (or its container)" be so marked.

If the article is a medical device and directly carries a label, and the country of origin is marked on that label, the requirement is satisfied and there is no further requirement.

If the device itself can't be labeled because of size, material type or some functional requirement but the pouch or label in which the device is distributed is labeled, the requirement is satisfied.

I don't know of any requirement that an IFU additionally must be labeled.

Keep in mind that this is a CBP rule, legally separate from the FDA's rules and enforcement procedures.
 
C

curiousone

#3
Re: Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling

MIREGMGR,
Thank you very much for your assistance; I did not know of any regulations requiring us to place it on the product insert as well. I am curioius however if there is a regulatory body that does require it to be done.:applause:
 

Sam Lazzara

Trusted Information Resource
#4
Last edited:
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