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EU IVD registrations - CFG or CFS - Differences

F

fondantcookie

#1
Hi all,

I'm relatively new to RA and I am getting increasingly involved with EU IVD registrations.

I have a number of requests for CFS (certificates of free sale) which I obtain from the MHRA (as the UKs competent authority).

I have also been informed I can access CFGs from our site in the US.

Please can anyone advise on the difference between these (ie CFS vs CFG) and whether or not certain countries have a preference?

Thanks in advance.
 
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pkost

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#2
CFG is a certificate to foreign government and it is issued by the US authorities to indicate that your product has been licensed/approved/cleared for sale in the US

CFS is a certificate of free sale is issued by a european authority and similarly indicates that the device is legally marketable in the EU (i.e. it has a CE mark).

There is little difference besides one comes from an EU country and the other the US. if a country accepts both there will be no preference as they merely prove that your product has jumped through some regulatory hoops to give them a level of assurance regarding your product.
 
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