✅ ÜTS Company Registration Guide: Step-by-Step Guide for Medical Device Companies

The Product Tracking System (UTS) is a digital platform that ensures traceability of medical devices in Türkiye, from production to end-user use. Managed by the Ministry of Health and the Turkish Medicines and Medical Devices Agency (TİTCK), this system aims to enhance product safety and oversight by recording the activities of medical device companies.

📌 Why is ÜTS Company Registration Mandatory?

• Legal Compliance: Medical device manufacturers, importers and distributors in Türkiye are required to register with the ÜTS before commencing their activities.

• Traceability: ÜTS enables tracking of the production, distribution and sales processes of medical devices.

• Market Inspection: Registered companies are subject to inspections regarding the safety and effectiveness of their products.

📄 Documents Required for ÜTS Company Registration

In order to register with ÜTS, medical device companies must prepare the following documents:

• MERSIS Number:

  The company's trade registry number.

• Tax Certificate:

  Current tax plate.

• Signature Circular:

  Signature circular of authorized persons.

• Medical Device Sales Center Authorization Certificate:

  Document obtained from the Provincial Health Directorate.

• Responsible Manager and Sales Representative Information:

  Qualification documents obtained from TCESIS.

• E-Signature or Mobile Signature:

  Electronic signature to be used in registration transactions.

🔄 ÜTS Company Registration Process

1. Login with E-Government or E-Signature:

   You can log in to the ÜTS portal.

2. Entering Company Information:

   MERSIS number, tax certificate and other information are entered into the system.

3. Identification of Authorized Persons:

   Responsible manager and sales promotion officer information is added.

4. Uploading Documents:

   Necessary documents are uploaded to the system.

5. Completion of the Application:

   The application is approved by e-signature and forwarded to TİTCK.

6. TITCK Approval:

   The application is reviewed and approved if deemed appropriate.

❌ Frequently Made ÜTS Company Registration Errors

• Incomplete or Incorrect Information Entry:

  Incorrect entry of information such as MERSIS number and tax certificate.

• Insufficient Documentation:

  Required documents are missing or invalid.

• Lack of Documents from Authorized Persons:

  The responsible manager or sales promotion officer does not have qualification documents.

• E-Signature Problems:

  The electronic signature is not valid or is not compatible with the system.

📊 ÜTS Company Registration Process Infographic

📥 Frequently Asked Questions

Is ÜTS company registration mandatory?

Yes. All companies operating in the medical device sector in Türkiye are required to register with ÜTS.

How long does the application process take?

If the documents are complete and accurate, the application is usually finalized within a few business days following TİTCK's review.

Can an application be submitted without an e-signature?

No. A valid e-signature or mobile signature is required for ÜTS applications.

💼 ÜTS Company Registration Consultancy

As Medex Medical, we offer professional consulting services to medical device companies regarding their ÜTS registration processes. Our expert team is here to help with accurate document preparation, system entry, and application tracking.

📞 Contact us: https://www.medexmedikal.com/iletisim

For detailed information, you can review our related article.