Regulatory Open Forum

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

I work with a Turkish manufacturer looking to sell their medical device in EU. Their device was approved by Turkish NB.
As Richard mentioned you need to have legal representative in the country and someone who will handle any questions from the authorities. Also you will need to translate a lot of documents into Turkish for the submission.

Have a good day.
Olga

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

In Turkey, foreign manufacturers of medical devices are required to appoint a local authorized representative in Turkey to submit the registration application on their behalf. This representative will be responsible for communicating with the relevant authorities and ensuring that all necessary documents and information are provided to complete the registration process.

Therefore, you cannot submit the registration application yourself, but you must appoint a local Turkish representative to act as your registration holder and submit the application for you through the Medical Device Tracking System (ÜTS). It is important to note that the representative must be a legal entity established in Turkey and authorized to carry out these activities.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello All,

I posted a similar question on the forum few months before with no success.
I agree that you need to select a Turkish rep but the next issue is to register to TITUBB when you are a Class I manufacturer.
The Turkish website request a CE certificate that you don't have when you are under Class I and it seems it doesn't accept the Declaration of Conformity.
If someone has a tip how to register to TITUBB when you are class I, I think it is the issue that is raised here...
Thank you,
Stephane.

In Turkey, foreign manufacturers of medical devices are required to appoint a local authorized representative in Turkey to submit the registration application on their behalf. This representative will be responsible for communicating with the relevant authorities and ensuring that all necessary documents and information are provided to complete the registration process.

Therefore, you cannot submit the registration application yourself, but you must appoint a local Turkish representative to act as your registration holder and submit the application for you through the Medical Device Tracking System (ÜTS). It is important to note that the representative must be a legal entity established in Turkey and authorized to carry out these activities.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

In Turkey, foreign manufacturers of medical devices are required to appoint a local authorized representative in Turkey to submit the registration application on their behalf. This representative will be responsible for communicating with the relevant authorities and ensuring that all necessary documents and information are provided to complete the registration process.

Therefore, you cannot submit the registration application yourself, but you must appoint a local Turkish representative to act as your registration holder and submit the application for you through the Medical Device Tracking System (ÜTS). It is important to note that the representative must be a legal entity established in Turkey and authorized to carry out these activities.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

Our company has recently analyzed the situation for Turkey. Our conclusions were:
-Turkey is handled for Medical devices as an EU country, as it has implemented MDR/IVDR and has an recognition agreement in place with EU.
- Turkish NB can make conformity assessment that is valid for EU.
- A EC REP appointed for third-party countries is also valid for Turkish authorities.

I do not see why an EU company would need to appoint an authorized representative in Turkey.

Have a nice day,
Enrico

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.

Hello,

I'm with Class I medical device manufacturer based in the EU that wants to sell their devices in Turkey.

We are aware we must register the devices first in the Turkish Product Tracking System (ÜTS).

However we have not found answer do we need to have a local Turkish representative, a registration holder, to submit the ÜTS registration, or can we do it ourselves.

Does anyone have experience how this goes?

We would appreciate your help very much.