Distribution medical devices to US Embassies

keldez

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#1
Hello,
Does anyone have experience or some evidence of FDA's stance on distributing to US Embassies in other countries without following the regulatory pathway to distribute to the country in which the US Embassy is located?

Hypothetical example, let's say I have a Class 2 Med device that is NOT CE-marked and I want to distribute it to the US Embassy in France and other EU countries. Anyone know of any allowances here?

Thanks
 

Sidney Vianna

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Staff member
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#2
I have the understanding that you need the CE-marking ONLY IF you are placing the product in the European market. So, if the devices would only be used in the embassies, by definition, they are NOT entering the regulated market. Why would the FDA care?
 

keldez

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#3
Apologies for any confusion there. CE and Europe were used as an example, and my question in that example should have been more geared toward "what would MDD/EU stance be on non-CE-marked product being distributed to US embassies within Europe Union countries?" I use this as a hypothetical because other international areas make the question more complex.
Interesting point on them not entering the regulated market. With my question a bit more clarified, still same stance? Thanks
 

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