Medical Device Registration in Turkey

C

cjr978

#1
Can anyone help me with the following question?
With the turkish heathcare system currently going through reform what registrations should manufacturers (Class I, IIa and IIb products - we are already registered in our home state, have a notified body and an authorised rep.) who are going to import through distributors in in Turkey complete? The Turkish DoH website is not the easiest to navigate and find out.
I have also found conflicting information on the net one says there are lots of regualtions, others say that as long as you are CE marked there is nothing.
thanks
 
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Stijloor

Staff member
Super Moderator
#2
Can anyone help me with the following question?
With the Turkish healthcare system currently going through reform what registrations should manufacturers (Class I, IIa and IIb products - we are already registered in our home state, have a notified body and an authorised rep.) who are going to import through distributors in in Turkey complete? The Turkish DoH website is not the easiest to navigate and find out.
I have also found conflicting information on the net one says there are lots of regulations, others say that as long as you are CE marked there is nothing.
thanks
Can someone help?

Thank you!!

Stijloor.
 

bio_subbu

Super Moderator
#3
Can anyone help me with the following question?
With the turkish heathcare system currently going through reform what registrations should manufacturers (Class I, IIa and IIb products - we are already registered in our home state, have a notified body and an authorised rep.) who are going to import through distributors in in Turkey complete? The Turkish DoH website is not the easiest to navigate and find out.
I have also found conflicting information on the net one says there are lots of regualtions, others say that as long as you are CE marked there is nothing.
thanks
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 “Republic of Turkey Drug and Medical Devices Databank”.

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
 

suildur

Involved In Discussions
#6
I am a Turkish and a consultant. Please contact me with pm for further questions, clearly stating what you need/want.
 

Stijloor

Staff member
Super Moderator
#7
I am a Turkish and a consultant. Please contact me with pm for further questions, clearly stating what you need/want.
We appreciate an open dialogue for the benefits of ALL our Members.

Thank you for your understanding.

Stijloor, Forum Moderator.
 

suildur

Involved In Discussions
#8
We appreciate an open dialogue for the benefits of ALL our Members.

Thank you for your understanding.

Stijloor, Forum Moderator.
:lmao: Am I right? Being a consultant here, doesnot mean you share your knowledge as a service.

I just wrote like that because the registration to Medical Devices Bank is sometimes a really big mess. They even don't answer phone calls when you have lots of questions to ask.

So, I meant not to bother others with discussing lots of bureaucratic works. That's all.:rolleyes:

Anyway, we can continue here, no worries.
 

Stijloor

Staff member
Super Moderator
#9
:lmao: Am I right? Being a consultant here, doesnot mean you share your knowledge as a service.

I just wrote like that because the registration to Medical Devices Bank is sometimes a really big mess. They even don't answer phone calls when you have lots of questions to ask.

So, I meant not to bother others with discussing lots of bureaucratic works. That's all.:rolleyes:

Anyway, we can continue here, no worries.
Maybe you misunderstood. When someone asks a question and the dialogue continues as private messages (PM), our Members who may also be interested in the discussion miss out on the information. That's all.

Stijloor.
 
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