Does supplier with manufacturing in US for EU market need Establishment Registration?
- Thread starter SGquality
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Re: Does supplier with manufacturing in US for EU market need Establishment Registrat
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 https://www.fda.gov/MedicalDevices/...egistrationandListing/ucm053165.htm#exportmfg
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 https://www.fda.gov/MedicalDevices/...egistrationandListing/ucm053165.htm#exportmfg
