Medical Device Registration in Turkey

suildur

Involved In Discussions
#11
If Turkey is a candidate and not a member state of the EU, then is the MDD applicable there in Turkey ?
All CE marking related directives are mandatory in Turkey. And, MDD is a must too -including GMP if the device's realted reference documents requires-.

Also, the National (Medical Devices) Data Bank is another step you have to encounter.
 
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C

cjr978

#13
Hi Welcome to Cove!!!

It is not any obligation to registration “Republic of Turkey Drug and Medical Devices information Bank” in terms of marketing of medical devices with respect to free circulation. However, if you want to sell your products to any government institute in Turkey, you have to register your products to

To complete this registration process, your distribution agent/ European Representative in Turkey must apply to Health Ministry with an application folder. The application folder has to include in some documentation according to MDD 93/42/EEC. (Letter of application, Declaration of conformity and CE Certificate also copies translated into Turkish of this documents, Compact Disk includes instructions for use and label information translated into Turkish).

For more detail about product registration to “Republic of Turkey Drug and Medical Devices İnformation Bank” please contact below mentioned address.

Ministry of Health
General Directorate of Pharmacy and
Parmaceuticals Biomedical Engineering
Department
Atatürk Bulvarı No: 657. Kat Sıhhiye 06343
Ankara/TURKEY
+90 312 3240248, +90 3123240378

Thats a great response and just what I was looking for. Thank-you
 
B

biomargam

#14
My post is quite delayed as had not been active on elsmar for a while due to other commitments. I am not sure if the information is too old to be useful.
I had a private email conversation with MOH , Turkey and whatever Mr. Subramaniam has provided is what is required. There is no requirement to register the device if you are not targeting Govt hospitals/clinics and CE mark is sufficient.

However, I understand majority are Govt controlled Health care system in turkey and so registration becomes necessary. As per the communication I had, the distributor needs to register on your behalf in Turkey

Documents needed

• CE certificate and all of its appendixes -
• Declaration of conformity- scanned copy
• IFU(instructions for use)- with CE Mark translated in turkish
• EAN 13 barcode
• Label of the sales unit- with CE Mark




Thanks
 
M

MIREGMGR

#15
I am not sure if the information is too old to be useful.
It's very useful to me, anyway.

• IFU (...) translated in turkish
Can you point us to the written requirement for this? I need to better understand if distinctions or requirement-differences apply to consumer-intended devices, professional-intended devices, etc., and what conditions are defined for provision of multi language labeling when space is insufficient on both the product and its immediate packaging.

• EAN 13 barcode
As above, can you point us to the written requirement? I need to better understand where this is to be provided in regard to a device (a sterile single-use disposable) that always is sold by the case, but that has individual-unit packaging within that case. We also need to know what size/readability requirements are stated or referenced.
 
C

chloep17

#17
Hi Suildur,

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

Many thanks.
 

suildur

Involved In Discussions
#18
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.
 
B

bharatbuk

#19
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.
 
S

sandiego

#20
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.
 
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