Medical device country of origin

#1
Can I ask please,
Since am new to medical devices.
If a medical device will be imported to the US shall the label mention the country of origin.
and if so, we are an Australian company, our contract manufacturer is located in Taiwan.
so is the statement "product of Taiwan" or "product of Australia" correct?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello Maria, welcome to the Cove (and to medical devices).

The FDA doesn't require the country of origin (COO) on the label.

The main requirement for specifying the COO is from CBP (the U.S. Bureau of Customs and Border Protection). The COO is also necessary for some FDA processes. Read here.

If your devices don't enter Australia the COO will be Taiwan.
 

Lokus200

Starting to get Involved
#3
Can I ask please,
Since am new to medical devices.
If a medical device will be imported to the US shall the label mention the country of origin.
and if so, we are an Australian company, our contract manufacturer is located in Taiwan.
so is the statement "product of Taiwan" or "product of Australia" correct?
Your label should state the legal manufacturer contact details.
 
#4
Thanks Lokus,

But as far as I know the FDA requires either the manufacturer or the distributor details to be mentioned on the device label
 

Ronen E

Problem Solver
Staff member
Moderator
#5
§801.1 Medical devices; name and place of business of manufacturer, packer or distributor.
(a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.
(c) Where a device is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such device; such as, “Manufactured for ___”, “Distributed by _____”, or any other wording that expresses the facts.
 
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