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Selling Class IIa Medical devices in Albania

B

Brain

#1
Can anybody please assit me with te requirements / Regulatins for selling class iiA electronic medical device in Albania? We already have CE mark on the device as well as FDA listing for the device and CMDCAS as well. Are there any additional requirements that have to be fulfilled in order to sell the device in Albania?

Thank you
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Can anybody please assit me with te requirements / Regulatins for selling class iiA electronic medical device in Albania? We already have CE mark on the device as well as FDA listing for the device and CMDCAS as well. Are there any additional requirements that have to be fulfilled in order to sell the device in Albania?

Thank you
Could you check these documents from Ministry of Health, Albania (from WHO website) and USAID - they have lot of info in there :)

Albania - Ministry of Health

Albania - USAID

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