MDR Medical Device Transactions
(Medical Devices Regulation-MDR) kapsamında gerçekleştirilen tıbbi cihaz işlemleri
ÜTS User and Company Transactions Help Guide
1. What is the Product Tracking System (ÜTS)?
The Product Tracking System (ÜTS) is an official system that performs the registration, tracking and follow-up transactions of medical devices and cosmetic products in Turkey in a digital environment. ÜTS is managed by the Turkish Medicines and Medical Devices Agency (TİTCK) and allows companies to register their products in accordance with legal regulations.
2. ÜTS User Transactions
2.1 User Registration
In order to log in to ÜTS, users must be authorized with e-Government integration.
Steps:
Enter the ÜTS Portal.
Log in with e-Government.
If you are a company official, complete your application with the “Company Official Application Form”.
After completing the TİTCK approval process, you will be authorized in the system as a company official.
2.2 User Authorization Transactions
A company official can add new users to the system or edit the authorizations of existing users.
Authorization Transactions:
In order to allow users to perform transactions on behalf of the company, authorization transactions must be performed via the ÜTS User Authorization Module.
Authorization levels can be determined and access to different transactions can be provided.
When adding a new user, the Turkish Republic Identity Number and contact information must be entered completely.
3. Company Transactions
3.1 Company Registration
In order for companies to perform transactions on ÜTS, they must be registered.
Information Required for Company Registration:
✔ MERSİS Number
✔ Tax Identification Number
✔ Trade Registry Gazette
✔ Company Official Information
✔ Contact and address information
How to Register a Company?
Log in to the ÜTS Portal.
Go to the “Company Transactions” section.
Select the “New Company Registration” option.
Complete your company registration by entering the necessary information.
After the approval process is complete, you can log in as a company official.
3.2 Company Authorized Person Identification and Change Procedures
A petition must be filed with TITCK to change the company authorized person.
The company authorized person can add more than one authorized person or edit the existing authorizations.
Users can access different modules by determining their transaction authorizations.
4. Medical Device Transactions within the Scope of ÜTS and MDR
4.1 What is Medical Devices Regulation (MDR)?
Medical Devices Regulation (MDR) is a European Union legislation that regulates the safety and performance of medical devices. In Turkey, MDR is also implemented within the scope of the Medical Device Regulation.
Main Requirements Under MDR:
Proving the safety and effectiveness of devices
Technical documentation and clinical evaluations
Conformity assessment procedures and CE certification
Monitoring products by registering them on ÜTS
4.2 ÜTS Registration Process for Products Under MDR
Companies that manufacture or import medical devices under MDR must perform product registration and tracking transactions through ÜTS. The transactions are carried out as follows:
Steps:
Log in to ÜTS.
Go to “Product Registration Module”.
Create a New Product Registration and enter the necessary information:
Product name, class and category
GTIN (Barcode) and UDI information
Technical files and conformity documents (CE Certificate, Clinical Evaluation, etc.)
Notified Body information
Complete the registration of your product and wait for the TİTCK approval process.
After receiving approval, the device can be placed on the market.
5. ÜTS Modules and Areas of Use
ÜTS has various modules for company transactions:
Modül Adı | Kullanım Amacı |
Firma İşlemleri Modülü | Firma bilgilerini güncelleme ve yetkilendirme |
Ürün Kayıt Modülü | Tıbbi cihaz ve kozmetik ürün kayıt işlemleri |
Onaylanmış Kuruluş Modülü | CE belgesi alımı ve uygunluk değerlendirme |
Takip ve İzleme Web Servisleri | Ürün hareketlerini izleme ve doğrulama |
Tekil Hareket Bildirimleri | Ürünlerin seri numarası bazında izlenmesi |
6. Common Problems and Solutions
⚠ Company Registration Not Approved:
✔ Make sure that MERSIS and Tax Identification information are entered correctly.
✔ Re-apply by completing the missing documents.
⚠ Product Registration Rejected:
✔ Make sure that the CE certificate and conformity assessment documents are complete.
✔ Check that the technical file is uploaded completely.
⚠ User Authorization Problem:
✔ Authorized user must log in and check user roles.
✔ Necessary authorization levels must be defined.
7. Conclusion and Summary
✔ ÜTS is a legally obligatory system that enables the registration, tracking and monitoring of medical devices and cosmetic products.
✔ Conformity assessment and ÜTS registration are mandatory for medical devices within the scope of MDR.
✔ Product registration procedures, approval processes and tracking mechanisms must be carried out carefully.
✔ Incomplete or incorrect operations may prevent the products from being placed on the market.