ÜTS Document Registration Consultancy

✅ ÜTS Document Registration Process: Required Documents and Detailed Guide for Medical Devices

The Product Tracking System (ÜTS) is a digital system implemented by the Ministry of Health and TİTCK to ensure the registration, traceability and control of medical devices sold in Turkey. It is mandatory for medical device manufacturers and importers to register with the ÜTS system before offering their products to the market.

In this content, you can find up-to-date and technical information about the ÜTS document registration process, required documents and common mistakes according to the classes of medical devices.

📌 What is a Medical Device?

A medical device is any tool, device, software, hardware or system that is used for diagnosis, monitoring, treatment or alleviation of disease on humans and does not have a pharmacological effect. According to the legislation, it is a legal obligation for all medical devices to be registered with ÜTS.

📄 Required Documents According to Medical Device Classes

Below, you can review the table prepared based on the TİTCK and Ministry of Health ÜTS Guides.

🔹 Class I (Low Risk)
Declaration of Conformity - Prepared by the manufacturer.
Technical File
User Manual and Label Information

Note: Class I devices generally do not require Notified Body approval.

🔹 Class IIa (Medium Risk)
CE Certificate (by Notified Body)
Declaration of Conformity
Technical File
User Manual and Label Information

🔹 Class IIb (High Risk)
CE Certificate
Declaration of Conformity
Technical File
User Manual and Label Information

🔹 Class III (Very High Risk)
CE Certificate (detailed inspection result)
Declaration of Conformity
Technical File
Clinical Evaluation Report
User Manual and Label Information

📌 Important Notes for Required Documents

Language: Documents must be in Turkish or supported by a sworn translation.
Format: PDF and e-signature are required.
Validity: CE documents are generally valid for 5 years; they must be renewed before expiration.

Consistency: Information such as company name, product model, barcode must be exactly the same in the documents and ÜTS records.

❌ Most Frequent ÜTS Document Registration Errors

Wrong class selection → wrong document upload
CE document expired
Technical file is incomplete or inconsistent
Product information does not match the barcode
Company name is missing or written incorrectly on the document

📥 Frequently Asked Questions

Is ÜTS registration mandatory?
Yes. All medical devices to be put on the market in Türkiye must be registered in the ÜTS system.

I get an error when uploading a document, what should I do?
The most common reasons: document format is incorrect (not PDF), document is unsigned, document expired, incomplete information. It is recommended that you get expert support.

💼 ÜTS Document Registration Consultancy

As Medex Medikal, we provide professional consultancy to medical device companies in ÜTS registration processes. We are with you in all steps of the correct classification, document control and upload process.

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

You can review our blog posts for detailed information.

https://www.medexmedikal.com/post/uts-belge-kayit-icin-gerekli-belgeler

https://www.medexmedikal.com/post/uts-kayit