Tanuna, kidev ertxel gigzavni cerils, just in case you did not receive my previous email:)

 

Many thanks in advance,

Nina

 

 

Tamuna, did madloba gamoxmianebistvis, imedia zalian ar shegacuxebs chemi shekitxvebit. Samcuxarod qartuli shripti ar maqvs da inglisurze gadaval, shenc shegacuxebs qartulis latinuri alpabitit cakitxva, cota didi mesijia amisatvis:)

 

So, I work for a UK company Product Compliance Specialists Ltd. We are a Global Type Approval company specializing in the international Type Approval of wireless communications products. 

 

One of our customers, Intertek Japan, has approached us to find out what are compliance requirements in Georgia for their medical device that they are planning to import and sell in Georgia.

 

I have already confirmed with Georgian National Communication Commission (GNCC) that devices with CE marking do not require compliance to local Georgian radio regulations as they comply to EU regulations already.

 

However, as this is a medical device being used in hospital setting (This product is intended to be used for capturing images and displaying them on a monitor), therefore we would like to obtain further information and confirm if it requires registration as a medical device or any other approvals before it is imported/sold in Georgia, based on relevant medical regulations currently in place.

 

I am attaching User Manual for the product for your reference, just for your information.

 

I would be very grateful if you could guide me in the right direction, so I can make sure we have all the information required so device fully complies with Georgian regulations.

 

I can imagine you are very busy and appreciate your time looking into this request.

 

Thank you in advance.

 

Kind regards,

Nina