CFS and Legeal manufacturer

Udirn1

Starting to get Involved
#1
Hi All,
I have a question which I would appreciate an insight on:
If the legal manufacturer of an already approved medical CE product s has an office in the USA and would like it to become the legal manufacturer for some markets by "duplicating" the "original" qms to the "INC" company.
would it be possible for the "INC" company to manufacturer the device in Europe and send to customers whilst on its Label there would be the "INC" company name or these devices are required to be shipped from the USA only?
Would it be possible in that case for the actual manufacturer (manufacturing site) to request from EU authorities CFS documents to support sales in countries out of the EU?
Thanks
Udi
 
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shimonv

Trusted Information Resource
#2
Hi Udi,
You are too vague.... and you cannot just "duplicate" the original QMS to another location, plus if it's a different legal entity new regulatory licenses are required.
 

Udirn1

Starting to get Involved
#3
Hi Shimon,
Assuming the INC establishment is all good and approved RA wise.
Can INC establishment manufacture in EU and ship from there?
 
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