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Selling a CE Marked Product to a Hospital in Bulgaria

S

srrbell

#1
#1
Hello all!

A hospital in Bulgaria wishes to purchase our CE marked product. I know Bulgarian Medical Devices is harmonized with the Directive 93/42/EEC, but can we sell directly to the hospital or do we need a distributor? Do the IFUs still need to be in Bulgarian?

Thanks for your help!
 
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Ronen E

Ronen E

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#3
#3
srrbell said:
Hello all!

A hospital in Bulgaria wishes to purchase our CE marked product. I know Bulgarian Medical Devices is harmonized with the Directive 93/42/EEC, but can we sell directly to the hospital or do we need a distributor? Do the IFUs still need to be in Bulgarian?

Thanks for your help!
Click to expand...
Hi,

I tend to think you don't need a local distributor and that the IFU need to be in Bulgarian, but I'm not sure. Perhaps you could work out the answers from the documents on this page:

http://en.bda.bg/index.php?option=com_content&view=category&layout=blog&id=10&Itemid=24

Cheers,
Ronen.
 
Ajit Basrur

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