Medical Device UTS Registration Consultancy

Medical Device UTS Registration Consultancy – Fast and Reliable Solutions with Medex Corporate Consultancy
The registration of medical devices in the Product Tracking System (UTS) is mandatory by the Turkish Medicines and Medical Devices Agency (TİTCK). Medical devices without a UTS registration cannot be sold, used or participate in public tenders in Turkey.

This process is a complex process that requires technical knowledge and regulatory information. As Medex Corporate Consultancy, we professionally manage the UTS registration process for medical device manufacturers, importers and distributors, ensuring that the process is completed completely and quickly.

1. What is Medical Device UTS Registration Consultancy?
📌 Medical Device UTS Registration Consultancy covers the processes of registering medical devices in the Product Tracking System (UTS) in accordance with TİTCK legislation, tracking them and preparing the necessary documents.

📌 Medical Device ÜTS Registration Consultancy services we offer as Medex Corporate Consultancy:

✅ ÜTS Company Registration – Registration of companies in the ÜTS system for manufacturers, importers or distributors.
✅ ÜTS Product Registration – Complete and error-free registration of medical devices in ÜTS according to their product classes.
✅ Technical File and Legislation Compliance – Preparation of documentation in accordance with MDR, IVDR and TİTCK regulations.
✅ Management of CE Certificate and Other Documents – Uploading mandatory certificates for medical devices to the system in accordance with ÜTS.
✅ Barcode (GTIN / UDI) Registration and Management – ​​Registration of products in accordance with international barcode systems.
✅ Authorization and Ownership Transfer Procedures – Updating and transferring medical device ownership in the ÜTS system.
✅ Audit and Compliance Controls – Ensuring that products comply with TİTCK legislation and international quality standards.

2. How to Register a Medical Device ÜTS Company?

Firms that want to register to ÜTS must first be included in the system as a manufacturer, importer or distributor authorized by TİTCK.

Required Documents for ÜTS Company Registration:
✔ Tax Certificate
✔ Trade Registry Gazette (Copy containing the company's establishment information)
✔ Signature Circular
✔ Authorized person information (E-signature authorized)

ÜTS Company Registration Process:
1️⃣ Application to ÜTS System

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