Does supplier with manufacturing in US for EU market need Establishment Registration?

SGquality

Quite Involved in Discussions
#1
If the manufactuer manufactures medical devices that are 100 % exported for EU market need to have an "Establishment Registration" with US FDA ?
 
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liuyy

Involved In Discussions
#2
Re: Does supplier with manufacturing in US for EU market need Establishment Registrat

Yes!Both registration and listing r needed.
 

Ajit Basrur

Staff member
Admin
#3
Re: Does supplier with manufacturing in US for EU market need Establishment Registrat

If the manufactuer manufactures medical devices that are 100 % exported for EU market need to have an "Establishment Registration" with US FDA ?
Yes this category falls under "U. S. manufacturer of export only devices" (Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries) need both Establishment Registration and Device Listing.

Refer http://www.fda.gov/MedicalDevices/D...egistrationandListing/ucm053165.htm#exportmfg
 
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