ÜTS Kullanıcı ve Firma İşlemleri

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 submitted to TİTCK to change the company authorized person.

The company authorized person can add more than one authorized person or edit the existing authorities.

Users can access different modules by determining their transaction authorizations.

4. ÜTS Modules and Areas of Use

ÜTS has various modules for company transactions:

5. Product Registration Procedures

The Product Registration Module is used for companies to add their products registered to ÜTS.

5.1 Product Registration Steps

Log in to ÜTS.

Enter the “Product Registration Module”.

Create a new Product Registration and enter the necessary information:

Product name and class

Barcode (GTIN) information

Technical specifications

Required documents (CE Certificate, Declaration of Conformity, etc.)

After the registration is completed, wait for the approval process.

After the approval is received, the product is registered to ÜTS.

6. Frequently Encountered Problems and Solutions

⚠ Company Registration Not Approved:

✔ Make sure that the MERSİS and Tax Identification information is entered correctly.

✔ Complete the missing documents and re-apply.

⚠ Product Registration Rejected:

✔ Make sure that the CE certificate and conformity assessment documents are complete.

✔ Check that the technical file is completely uploaded.

⚠ User Authorization Problem:

✔ Authorized users 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.

✔ Companies can perform transactions on ÜTS through authorized users.

✔ Product registration transactions, approval processes and tracking mechanisms must be carried out carefully.

✔ Incomplete or incorrect transactions may prevent products from being placed on the market.