Medical device registration in Türkiye: how ÜTS works
Who registers medical devices in ÜTS, in which order, what differs for importers and for manufacturers in Türkiye, and what the May 2026 guide says.
Ten questions about registering a medical device in ÜTS, the Turkish product tracking system. Every answer rests on a document published by TİTCK, SGK or DMO, and the source is named under the answer. Where we speak from our own work in ÜTS instead, the answer says so. The official documents are in Turkish. This page summarises them and is not a translation.
What is ÜTS, and who has to register?
ÜTS (Ürün Takip Sistemi, the Product Tracking System) is the Turkish system that registers medical devices, cosmetics and certain biocidal products made in Türkiye or imported into it. Since 12 June 2017, devices placed on the market under the Turkish medical device regulations have been registered there, together with their documents. TİTCK, the Turkish Medicines and Medical Devices Agency, assesses the applications.
Registration starts with the firm. A firm that sells or applies medical devices registers in ÜTS once the legislation has authorised it. One that registers under the firm type for manufacturers, importers, dealers and exporters needs a medical device sales centre licence and enters its ÇKYS number during firm registration.
When the manufacturer is outside Türkiye, the importer registers the manufacturer's documents first and then the device, which ÜTS records as imported.
Sources: TİTCK, Ürün Takip Sistemi page; TİTCK registration guide TCKKD-KLVZ-03, Articles 5, 12 and 27. Last checked 2 October 2026.
In which order does registration run?
First the firm, then its users, then the documents, then the devices, and after that the notifications for single products. TİTCK gives this order on its ÜTS page and adds that a firm registers a device's documents before the device itself.
A device counts as registered only after an application that TİTCK assesses. A document application holds at most five documents, and a device application of the usual kind at most 500 devices. Under the MDR and IVDR, one application may hold only devices that share a Basic UDI-DI, with custom-made devices as the exception.
On this page, as in TİTCK's guide, MDR and IVDR mean the Turkish regulations published in the Official Gazette of 2 June 2021.
Sources: TİTCK, Ürün Takip Sistemi page; TİTCK registration guide TCKKD-KLVZ-03, Articles 4, 39 and 40. Last checked 2 October 2026.
What is different for an importer?
An importer registers documents that a manufacturer abroad issued, so TİTCK's guide lists the forms in which TİTCK accepts them. For the manufacturer's declaration of conformity there are four: the document with an apostille; the document approved by the Turkish embassy or consulate in the manufacturer's country; the original of a document with an e-apostille; or the original of a document the manufacturer signed electronically, provided the signature can be verified. The importer uploads a sworn Turkish translation with it.
A manufacturer established outside both the EU and Türkiye needs an EU authorised representative. The importer uploads the mandate, or instead a printout of the manufacturer's actor page in EUDAMED that shows the authorised representative.
In the device record, a device counts as imported when the manufacturer that issued its declaration of conformity is not established in Türkiye. The country it is imported from and its customs tariff number (GTİP) are then mandatory fields.
Imported products enter ÜTS with an import notification. Before making it, the firm opens a quota for the product, using the item number of the customs declaration.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Articles 12 and 27; ÜTS, descriptions of the notifications. Last checked 2 October 2026.
What is different for a manufacturer in Türkiye?
A manufacturer in Türkiye registers its own declaration of conformity, signed electronically. The guide requires the application type "İmalatçı Firmalar için e-imzalı Belge Başvurusu" (e-signed document application for manufacturers). ÜTS lets the application through only when the firm's responsible manager or its authorised signatory signed the document electronically. TİTCK accepts declarations whose original language is Turkish.
For products registered as made in Türkiye, ÜTS checks the barcode and the firm that owns it with GS1 Türkiye.
Products made in Türkiye enter ÜTS with a production notification. The deadline, in force since 31 March 2023, is 120 days from production.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Article 13; TİTCK, Ürün Takip Sistemi page; ÜTS, descriptions of the notifications. Last checked 2 October 2026.
What does the May 2026 registration guide say about paper documents?
It says an importer need not send them, and the ÜTS screen works that way today. In our own work, the importer screen asks for the documents to be uploaded and does not ask for paper (October 2026).
The rule changed with the 2026 guide. Under announcement 2022/KK-1, TİTCK did not examine a document application unless the same documents reached it on paper. Article 12 of the 2026 guide says the documents uploaded as the original and as the Turkish translation need not be sent to TİTCK on paper. Article 69 ties Articles 8, 12 and 15 to the ÜTS release in which their procedure works technically. If your screen asks for something else, follow the screen and ask TİTCK.
The guide's number is TCKKD-KLVZ-03. It took effect on 13 May 2026, has 316 pages and repealed the guide of 15 November 2022 (TCKKD-KLVZ-01, Rev.1). Where an announcement and the registration guide disagree, TİTCK states that the guide prevails.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Articles 12, 68 and 69; announcement 2022/KK-1; TİTCK, Ürün Takip Sistemi page. Last checked 2 October 2026. What the screen asks for is our own observation, not a quote from these documents.
Who confirms and signs the application, and what can a consultant do?
The firm's own users confirm and sign. Only users of the type "Tıbbi Cihaz Kayıt Elemanı" (medical device registration staff) can confirm an application, and the firm's authorised signatory signs it electronically. Once the fee is paid, the application is under examination at TİTCK. A consultant can prepare and check the files. Inside ÜTS, the two limits below apply.
Firm, document and product applications have carried a fee since 28 May 2024. The amounts are in TİTCK's price tariff.
In 2024 TİTCK set two limits for people who work for several firms:
- A user who is defined in more than one firm can add documents and products, but cannot send an application to TİTCK.
- One person can be defined as a firm user in at most 10 firms.
TİTCK's stated reason is data security and responsibility where the people who register are not the firm's own employees. So someone outside the firm can prepare and check, and the firm's own users confirm, sign and pay.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Articles 39 and 40; TİTCK announcement of 27 May 2024; ÜTS announcement of 20 September 2024; ÜTS announcement of 25 October 2024. Last checked 2 October 2026.
Which notifications follow registration?
After registration, ÜTS tracks every unit by its serial or lot number, through notifications. A product enters ÜTS with a production, import or inventory notification. It moves with giving and receiving notifications, and it leaves with a notification of use, consumption, giving to the consumer, scrap or loss, or destruction.
A giving notification is not enough on its own. The receiving party has to make a receiving notification, and without it the stock does not move. Products given free of charge need a giving notification too, and exported products get an export notification.
The first notification is an import notification after a customs quota, or a production notification within 120 days, as the importer and manufacturer answers above describe.
Sources: TİTCK guide on single-movement notifications, Articles 5 and 9; TİTCK, Ürün Takip Sistemi page; ÜTS, descriptions of the notifications; ÜTS, training page and FAQ. Last checked 2 October 2026.
Where are the Excel templates?
Inside ÜTS, after sign-in. For devices, the registration guide places the bulk screens under "Toplu İşlemler" on the "Tıbbi Cihazlarımı Listele" screen: one for MDR devices, one for IVDR devices and one for devices under the old regulations (MDD, AIMDD, IVDD). You download the template on that screen, with "Şablon Excel Dosyası İndir".
The guide sets three rules for the template:
- Red columns are mandatory. Yellow columns are mandatory depending on another field.
- You upload the workbook in one zip file, together with the label and packaging files. The zip may be at most 200 MB, and file names may not contain Turkish characters.
- A bulk upload registers nothing by itself. A device application to TİTCK still has to follow.
Movement notifications have a template of their own, under "Ürün Hareketleri", "Excel ile Toplu Bildirim". The firm fills in the current template following its information sheets and uploads it without removing a column, row or sheet.
We do not offer the templates for download. The ÜTS user agreement makes publishing TİTCK's material on another site subject to TİTCK's permission, and ÜTS expects the current template in any case.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Articles 31, 32 and 33; TİTCK guide on single-movement notifications, Article 29; ÜTS, training page and FAQ; TİTCK, Ürün Takip Sistemi page (user agreement). Last checked 2 October 2026.
Does registration in EUDAMED replace registration in ÜTS?
No. We found no rule in TİTCK's registration guide that accepts a registration in EUDAMED in place of a record in ÜTS. Devices placed on the Turkish market and their documents are registered in ÜTS. The data you prepared for EUDAMED still helps, because ÜTS asks for much of the same.
What carries over:
- The UDI-DI and the Basic UDI-DI are mandatory fields of an MDR device record in ÜTS. The guide describes the Basic UDI-DI as what links a group of devices in EUDAMED, in ÜTS and in their documents.
- EMDN is the nomenclature used for registration in both systems.
- The manufacturer's SRN, when it has one, has a field of its own.
- A printout of the manufacturer's actor page in EUDAMED can stand in for the authorised representative's mandate.
What ÜTS asks for in addition:
- A GMDN code, which is mandatory.
- For an imported device, the country it is imported from and the customs tariff number.
- The reimbursement and Sağlık Market fields described in the next answer.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Articles 4, 7, 12 and 27; TİTCK, Ürün Takip Sistemi page. Last checked 2 October 2026.
How do SUT reimbursement and DMO Sağlık Market depend on ÜTS?
Both depend on the ÜTS record. A device record in ÜTS has two mandatory fields about them: the SUT matching status, and whether the device will be sold in Sağlık Market or reimbursed by SGK. A device for which SUT matching will be requested also needs a Turkish catalogue in ÜTS.
SGK is the Social Security Institution, and SUT holds its reimbursement rules for medical supplies. Applications that match a SUT code to a barcode go through SGK's own application address. SGK does not accept them through ÜTS or by hand. It takes applications in periods: twice a year for group A, twice for group B and three times for group C.
Sağlık Market is set up within DMO, the State Supply Office. Firms that apply for its framework agreement on medical supplies need up-to-date ÜTS records for themselves and for the products they offer. Each offered product also needs at least three photographs in ÜTS.
eudaflow's first service for Türkiye covers registration in ÜTS and the first notification. We quote work on SUT and Sağlık Market applications on request.
Sources: TİTCK registration guide TCKKD-KLVZ-03, Article 27; SGK, how medical supplies enter reimbursement; DMO, announcement of the Sağlık Market framework agreement for medical supplies. Last checked 2 October 2026.
What eudaflow does, and what it does not
eudaflow prepares your documents and your device file for ÜTS and checks them before upload. If you already have a checked EUDAMED data set, we start from it. We can join remotely while your authorised person uploads and signs, and we go through the first production or import notification with you. Our team has registered documents and devices in ÜTS before, for importers and for manufacturers.
Your own staff confirms and signs the application in ÜTS and pays the fee. We do not send applications to TİTCK, and we never ask for your password or your e-signature. We do not decide a device's class, assess conformity or give legal opinions. TİTCK decides on every application, so we cannot promise the outcome or how long it takes.
Sources and how we checked
Every statement about a rule is tied to a short quote in a claims register. Before we publish, a script compares each quote with the current text of its source. The statement about what the importer screen asks for comes from our own work in ÜTS instead, and says so.
The official documents are in Turkish and they change. TİTCK updates its pages, its fee tariff and ÜTS itself. Read the current official text before you rely on a detail for a specific application. This page is general information, not legal advice.
TİTCK, SGK and DMO set these rules. eudaflow is not affiliated with any of them.