ÜTS Registration Consultancy

ÜTS Consultancy – Fast and Reliable Solutions with Medex Corporate Consultancy
Product Tracking System (ÜTS) is a mandatory system carried out by the Turkish Medicines and Medical Devices Agency (TİTCK) covering the registration, monitoring and control processes of medical devices, cosmetic products and biocidal products.

Products that are not registered with ÜTS cannot be placed on the market, sold or purchased by public institutions. Therefore, ÜTS registration is mandatory for medical device manufacturers, importers, distributors and suppliers.

As Medex Corporate Consultancy, with our ÜTS consultancy service, we ensure that your company and products are registered with ÜTS without errors and quickly.

1. What is ÜTS Consultancy?
📌 ÜTS Consultancy covers the processes of registering medical devices and other products with ÜTS in accordance with TİTCK legislation, ensuring product tracking and preparing the necessary documents.

📌 As Medex Corporate Consultancy, the ÜTS Consultancy we offer includes the following services:

✅ ÜTS Company Registration – Registration of companies to the ÜTS system for medical device manufacturers, importers and suppliers.
✅ ÜTS Product Registration – Error-free and fast registration of medical devices and other products to the ÜTS system.
✅ Product Categorization and Technical File Preparation – Correct classification of products and preparation of technical files in accordance with relevant regulations.
✅ Regulatory Compliance Checks – Conducting compliance checks for national and international regulations such as TİTCK, MDR/IVDR, ISO 13485.
✅ ÜTS Document Registration and Management – ​​Uploading the CE certificate, warranty certificate, technical documents and other mandatory documents that should be included in the ÜTS to the system completely.
✅ Product Tracking and Updates – Updating product information, performing authorization and ownership transfer transactions.
✅ Consultancy and Training in the ÜTS Process – Providing training and consultancy to companies on ÜTS processes.

2. How to Register a Company in ÜTS?
Companies that want to register in the ÜTS system must first be included in the system as a company authorized by TİTCK.

Documents Required for ÜTS Company Registration:
✔ Tax Certificate
✔ Trade Registry Gazette (Copy containing the company's establishment information)
✔ Signature Circular
✔ Industrial Registry Certificate (For manufacturing companies)
✔ Distributorship Authorization Certificate (For authorized distributors)
✔ ISO 13485: Quality Management System Certificate for Medical Devices (Recommended)
✔ Authorized person information (E-signature authorized)

ÜTS Company Registration Process:
1️⃣ Application to ÜTS System

As Medex Corporate Consultancy, we manage TİTCK authorization processes and perform your company application to the ÜTS system.
2️⃣ Uploading Required Documents

By logging into the ÜTS system, company information is entered completely and without errors.
3️⃣ Authorization and Approval

If the application reviewed by TITCK is complete, it is approved and your company is authorized in the ÜTS system.

3. How to Register a Product in ÜTS?
Medical devices, biocidal products and cosmetic products must be registered in ÜTS. Products that are not registered in ÜTS cannot be sold and cannot be included in public procurement.

Documents Required for ÜTS Product Registration:
✔ TİTCK ÜTS Company Registration Certificate
✔ CE Certificate (For medical devices)
✔ ISO 13485 Certificate (Recommended for medical device manufacturers)
✔ Product Technical File
✔ Warranty Certificate and User Manual (Must be in Turkish)
✔ Product Introduction Brochure or Catalog
✔ Barcode Number and GTIN / UDI Information
✔ Product Class and Risk Group (Class I, IIa, IIb, III etc.)

ÜTS Product Registration Process:
1️⃣ Entering Product Information into ÜTS System

Details such as the product name, model, technical specifications, area of ​​use, medical class are recorded completely into ÜTS.
2️⃣ Uploading Necessary Documents to the System

CE certificate, warranty certificate and all other mandatory documents are uploaded completely into ÜTS.
3️⃣ Product Classification and Approval Process

Necessary checks are made to ensure that the products are in the correct class and approval is received from TİTCK.

4. Advantages of Receiving ÜTS Consultancy Service
✅ Fast and Error-Free Application Process
✅ Compliance with TİTCK and EU Legislation
✅ Reducing the Risk of Incomplete or Incorrect Applications in the ÜTS Registration Process
✅ Advantage of Participating in Public Tenders
✅ Time and Cost Savings

5. Simplify Your ÜTS Process with Medex Corporate Consultancy!
ÜTS registration is a complex and detailed process for companies. As Medex Corporate Consultancy, we ensure that your company and products are fully registered in ÜTS.

📞 Contact us to get detailed information about our ÜTS consultancy service and get professional support!