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Republic Of Georgia Medical Device Regulations for IVD

#1
Hi,

I'm researching the medical device regulations for the Republic of Georgia and am having a hard time finding anything too specific. I found a document from 2011 called "Overview and Legal Analysis of Healthcare Legislation" (attached) which talks about medical device registration requirements, but it states that there is no current (as of 2011) supervision or control of medical devices that are on the market there.

I was wondering if anyone had any more up to date information on what the regulations are in Georgia now or if they could elaborate on the process / oversight as it is today.

Thanks much!!
 

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Gamula

Involved In Discussions
#4
Dear EyesWideOprn,

thank you for the data.

I have a question regarding the medical device registration:

We have a CE mark for all of our devices which are ranging from class 1 till class 3.

Now, I do not understand the registration in Gerogia, it is almost a member of the EU and it still has its own non-transparent regulations. We try to understand the demand of an own registration procedure together with the problem, that they just gave us information via our local agent.

Now, who is also not understanding this situation.

Best
Gamula
 
D

Dirk_REGULA

#5
Dear all,

I'm also looking for medical device registration requirements in the Republic of Georgia.
Does anyone have any news?
Thanks a lot,
Dirk
 

Gamula

Involved In Discussions
#6
Hi Dirk_REGULA,

here is a general list of items, wich will be needed for registration. But, ask your agent or an agency for detailled data.

1) The letter on behalf of firm for your representatives
2) Information on a product, the structure if what it consists.
3) The supporting document the product is registered in e. g. Germany and on what the period of time it (it is termless)
4)Instruction, quality certificates ISO or EC certificate.
5) Identification number for the license for trade.
6) Production method
7) Data on item that it is not toxic, not mutagen.
8) Original model of marking .
9) Release form, structure set.
10) Sample.

If you get more information we would like to get them shared :agree1:

Cheerio!
 
#7
Does anyone have more information about medical device regulations in Georgia?
-Is local representative required?
-Is registration mandatory for Class I device?
-any specific labeling requirement?
 
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