Medical Device Registration in Turkey

[chloep17]

Hi Suildur,

Are you able to advise whether Class I ancillaries and instrumentation must be registered with the Databank?

Many thanks.

[suildur]

Okay, here is the website of the databank:

http://ubb.iegm.gov.tr/

You will see the English version link on the top right of the screen. However, it directs you a very limited English version, and, it is not effective.

Anyway, there, on that address, the online application and the product registration process after the approval of the application can be done, but in Turkish.

And, to answer your question, I can clearly state that you donot need to register your company and your products if you won't sell those to goverment or goverment related organizations. However, this is nearly impossible for most of the products, thus, you ought to register anyway. Because, if there are other companies which have registered their products and if those products are paid back by the health funding system, you will not be able to compete with them as anyone will choose to buy those products instead of your products.

I hope that was helpful. If you need more assistance come back.

[bharatbuk]

The prospects for the medical device market in Turkey remain good; by strong import growth trends, for which the country relies heavily on, and the expansion of healthcare facilities coupled with rising health expenditure should see the market grow at an attractive rate of 7.4% in the 2011-2016 period. The market is currently the largest in the region, and is among the top 30 in the world.

[sandiego]

Dear all:
Where can it be confirmed that only EAN-13 bar-coding is acceptable for product sold in Turkey? Our distributor is not accepting GS1 bar-coding on CE marked products.
Thank you.

[cjr978]

Hi there,
Are you referring to the barcode style or the actual number contained?

EAN13 numbers are GS1 GTIN 13 numbers - so the numbers are the same thing

For retail packaging (i.e. a device sold in a shop) then the EAN13 style would be customary as that would be the type of barcode that a retail establishment can read

For most other medical devices a GS1-128 barcode format is pretty much the norm, that encodes the same GTIN number and also things like the lot and expiry.

With our products as long as the distributor registers our GTIN numbers then the packaging has been irrelevant, but they are surgical implants.

If you explain what type of product you have i may be able to be more use.

[sandiego]

Thank you cjr978:
I am referring to the Barcoding. The products are controls, calibrators and reagent which are used by diagnostic laboratories. They are for professional use only.

[geglee05]

Hi, do we need to have distributor to register for us? Or a local representative (like EAR for example) can help to register too? And the license will belong to who if distributor is registering? Distributor or manufacturer? We are thinking if a local representative is ok to register, we can have a few distributors in Turkey. Besides the potential distributor asks for the technical file in order to register. Quoting that it is mandatory. Is it true? Thanks.