Medical Device Registration in Turkey

C

cjr978

#21
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.
 
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S

sandiego

#22
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.
 
G

geglee05

#23
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.
 
V

vitols

#24
Hi to everyone,

my question is quite similare to that submitted by geglee:

"I'm a foreign manufacturer (but resident within an Europen Community Country) and I want to registrate my Medical Device in the turkish TITTUB database.

my question is:

Shall I appoint a distributor (who is the only qualified subject to carry out the registration) or, conversely, also the foreign manufacturer can enrole himself in TITTUB and then register his medical device indipendentily by himself (that is without distributor's help?)"

Thanks a lot!

Bye,
Vitols
 

suildur

Involved In Discussions
#25
Hi to everyone,

my question is quite similare to that submitted by geglee:

"I'm a foreign manufacturer (but resident within an Europen Community Country) and I want to registrate my Medical Device in the turkish TITTUB database.

my question is:

Shall I appoint a distributor (who is the only qualified subject to carry out the registration) or, conversely, also the foreign manufacturer can enrole himself in TITTUB and then register his medical device indipendentily by himself (that is without distributor's help?)"

Thanks a lot!

Bye,
Vitols
Well, you may not continue for yourself with the registration.

You have to register "a" company at first for the begining. And they ask local tax numbers etc. So, you need a distributor. And, the site is in Turkish. And, you need an electronic signature device (i.e., which comes with usb sticks) to continue with the process after the registration.

Also, the paper work is really heavy and strict.

Good luck.
 

sreenu927

Quite Involved in Discussions
#27
Hi - Our product is an IVD instrument, which is a Self-Declared CE marking device.
Does it requires registration in Turkey? If so, what are the requirements for IVDs?

Thanks,
Sreenu
 

tibon74

Involved In Discussions
#28
Could someone answer to the questions below? I'm also interested
"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. "

thank you!
 

suildur

Involved In Discussions
#29
Could someone answer to the questions below? I'm also interested
"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. "

thank you!
Yes you need a distributor, or your own Turkish company, to register. Because UBB (Ulusal Bilgi Bankasi - National Data Bank) needs a tax number registered in Turkey.

I donot understand what you mean with license, but if you are talking about trade/product rights, you have to make a distributor agreement with the distributor.

And, as far as I know, it is not possible to have different distributors for only one device. Who will bear the responsibility of that device then in means of the MDD? You will have a general distributor, then, she will distribute it to local retailers.

And the technical file... Well, most of the time, it is not needed as a whole, but some parts of the file will be needed even at registering phase. On the other hand, the officials strictly control the market. The post market witness auditors from the MoH will probably ask for the technical file when they accidently/randomly inspect the distributor company. So, it is a must, too.

Also, check my previous posts, I have described in details.

And, having different distributors... It is discussed here:

http://elsmar.com/Forums/showthread.php?t=56367
 
Last edited:

tibon74

Involved In Discussions
#30
Hi, thank you !
for the license, I'm talking about the registration certificate.
If our distributor is the AR (authorized representative) could I send the products directly to another one or we should go through first by the AR?
Could I change the AR of a product? if so how ?
 
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