Medical Device UTS Registration Consultancy

Medical devices without a registration in ÜTS — the system mandated by the Turkish Medicines and Medical Devices Agency (TİTCK) — cannot be sold, used or tendered for in Türkiye. The process is technically demanding and requires regulatory mastery and meticulous file management. Medex Corporate Consultancy manages the entire ÜTS registration process end-to-end for medical device manufacturers, importers and distributors, ensuring complete, fast and audit-ready outcomes.
📋 Regulatory Framework
The registration of medical devices in ÜTS is governed by both national and European Union regulations.
National Legislation

Medical Device Regulation (Official Gazette 02.06.2021/31499 Repeated)
In Vitro Diagnostic Medical Device Regulation (02.06.2021/31499 Repeated)
Medical Device Sales, Advertising & Promotion Regulation
ÜTS Data Processing Guideline (TİTCK)

EU Legislation & Standards

MDR 2017/745 — Medical Device Regulation
IVDR 2017/746 — In Vitro Diagnostic Regulation
EUDAMED — European database (mandatory from 28 May 2026)
ISO 13485 — Medical device quality management system
ISO 14971 — Medical device risk management

👥 Who Must Register in ÜTS?
All actors in the medical device supply chain must be registered in the ÜTS system:

Manufacturer — Companies producing medical devices in Türkiye
Importer — Companies importing foreign-origin devices
Distributor — Medical device distribution and sales networks
Authorised Representative — Representatives acting on behalf of foreign manufacturers in Türkiye

🏷️ Medical Device Classification
The MDR and Türkiye's Medical Device Regulation classify devices into four risk-based classes. Class directly determines the documentation burden and approval timeline.
Medical Devices (MDR 2017/745)

🟢 Class I — Low Risk: Self-declaration. Examples: stethoscopes, eyeglasses, wheelchairs, surgical masks, basic dressings.
🔵 Class IIa — Low–Medium Risk: Notified Body required. Examples: hearing aids, contact lenses, dental fillings, ultrasound devices.
🟡 Class IIb — Medium–High Risk: Notified Body required. Examples: ventilators, anaesthesia machines, infusion pumps, X-ray devices.
🔴 Class III — High Risk: Design dossier review. Examples: heart valves, pacemakers, hip/knee implants, brain implants.

In Vitro Diagnostics (IVDR 2017/746)

🟢 Class A — Low Risk: General lab. Examples: reagents, buffer solutions, sample containers.
🔵 Class B — Medium Risk: Self-testing. Examples: pregnancy tests, cholesterol tests, urine analysis strips.
🟡 Class C — High Risk: Disease screening. Examples: cancer markers, genetic tests, glucose meters.
🔴 Class D — Critical Risk: Public health. Examples: HIV and hepatitis tests, blood typing, transfusion safety.

🏢 ÜTS Company Registration: Step-by-Step
Before registering products in ÜTS, the company must first be approved by TİTCK as an actor in the system.
1. Access ÜTS via E-Government
The authorised individual logs in to the ÜTS platform with their e-signature. ÇKYS code and authorisation document must be ready.
2. Complete the Company Registration Form
Company name, MERSİS number, tax details, authorised personnel and contact information are entered.
3. Upload Documents
Tax certificate, trade registry gazette, signature circular and authorisation document are uploaded as PDF.
4. TİTCK Review & Approval
Documents are reviewed by Agency experts. Incomplete files are rejected; complete files are approved. Duration: 5–15 business days.
5. Authorisation & Responsible Person
Users authorised to act on the company's behalf are designated; the Person Responsible for Regulatory Compliance (PRRC) is registered.
📦 ÜTS Product Registration: Step-by-Step
Product registration is performed device by device. Each product's class, technical specifications and documents are individually defined in the system.
1. Enter Product Information by Class
Product name, commercial name, model, GMDN code, class (I/IIa/IIb/III or A/B/C/D) and UDI/GTIN-14 barcode are entered.
2. Match Documents
The product is linked to the previously registered CE certificate, declaration of conformity and technical file in ÜTS.
3. Upload Turkish Label & IFU
The Turkish label and Instructions For Use (IFU) for the product are uploaded as PDF.
4. Class-Specific Additional Documents
For Class IIa and above: CE certificate, sterilisation validation report, clinical evaluation report.
5. TİTCK Approval & Publication
Once approved, the product becomes active in ÜTS and is listed in the TİTCK public database. Duration: 5–10 business days.
✅ Required Documents
For Company Registration:

Tax Certificate
Trade Registry Gazette
Signature Circular (notarised)
E-Signature Authorisation
PRRC Information
Activity Certificate

For Product Registration:

CE Declaration of Conformity
CE Certificate (Class IIa and above)
Technical File (MDR/IVDR compliant)
Turkish Label Image
Turkish IFU
GMDN Code
UDI / GTIN-14 Barcode
Clinical Evaluation Report
Risk Analysis (ISO 14971)
Sterilisation Validation Report (if applicable)

⚠️ Common Pitfalls
Drawing on 15 years of field experience, here are the most common reasons ÜTS applications get rejected. In Medex's process, every one of these is systematically checked before submission.

Wrong Classification: Mis-classifying the device under MDR Annex VIII — e.g. registering a Class IIb device as IIa — leads to rejection and downstream legal exposure.
Incomplete or Faulty Turkish Label: Missing mandatory information on the Turkish label (manufacturer, importer, lot, expiry, symbols) is the single most frequent cause of rejection.
Expired CE Certificate: The Notified Body-issued CE certificate has lapsed, or the renewal application has been overlooked.
Missing Sworn Translation: Foreign-language documents submitted with notary-only translation. TİTCK now requires translation signed by a sworn translator.
Incorrect GMDN Code: The GMDN code does not fully reflect the device's function — causing problems both in registration and in tenders.
UDI Format Error: The GTIN-14 barcode is not GS1-compliant, or the AI (Application Identifier) format is misused.
Manufacturer–Importer Inconsistency: Manufacturer address on the CE certificate does not match the manufacturer information registered in ÜTS.

⏱️ Process Timelines

Company Registration: 5–15 business days
Document Registration: 7–21 business days
Product Registration: 5–10 business days
Class III Extra Time: 3+ additional business days may be required

🛠️ Services We Provide

ÜTS Company Registration — Complete company registration in the ÜTS system for manufacturers, importers and distributors.
ÜTS Product Registration — Class-aware, error-free registration of medical devices in ÜTS.
Technical File & Regulatory Compliance — Preparation of technical documentation aligned with MDR, IVDR and TİTCK requirements.
CE Certificate & Document Management — Upload and lifecycle management of mandatory medical device certificates in ÜTS.
Barcode (GTIN/UDI) Registration & Management — Registration of products in compliance with international barcoding systems.
Authorisation & Ownership Transfer — Updating and transferring medical device ownership in the ÜTS system.
Audit & Compliance Checks — Ensuring product compliance with TİTCK and international quality standards.
Sworn Translation & Apostille — Sworn-translator-certified translations for English, German, Italian and other languages.

💼 Why Medex Corporate Consultancy?
100% Regulatory Alignment — We follow the TİTCK Medical Device Regulation, MDR 2017/745, IVDR 2017/746 and EUDAMED procedures daily, structuring your applications to the latest version in force.
Fast and Accurate Submissions — Every rejection means lost time and revenue. Our multi-stage internal review catches errors before submission, not after.
Immediate Support on Deficiencies — We respond to TİTCK deficiency notices within 48 hours and rebuild the application for resubmission.
Audit-Ready Technical File — We don't just register — we build an MDR/IVDR and ISO 13485-compliant technical file ready for inspection day.
Multilingual Translation Support — Sworn-certified translation services in English, German, Italian and other European languages.
Domestic vs Imported Workflow Separation — We manage the distinct documentation and procedural requirements of domestic manufacturers and importers separately.
❓ Frequently Asked Questions
My ÜTS application was rejected — what should I do?
The rejection reason is communicated by TİTCK through the system. The deficiency is usually in a document, label or GMDN code. Don't simply resubmit — a second submission without remedying the issue will be rejected again. If you bring it to Medex, we analyse the rejection reason and prepare a clean resubmission within 48 hours.
How long does the entire process take?
With complete documents: 5–15 business days for company, 7–21 for documents, 5–10 for products. Class III devices may need additional review. Expect 3–6 weeks from first submission to a market-ready product on average.
Is a Turkish label and IFU mandatory?
Yes. Under the Medical Device Regulation, every device sold in Türkiye must have its label information and Instructions For Use (IFU) in Turkish. Foreign-language labels or IFUs cause immediate rejection.
If the manufacturer is overseas, who registers in ÜTS?
For devices manufactured outside Türkiye, registration is done either via a Türkiye-based Authorised Representative or via an Importer company. The Authorised Representative communicates with TİTCK and other authorities on the manufacturer's behalf and assumes responsibility.
I don't have a CE certificate — can I still register in ÜTS?
Class I devices can be registered with a self-declaration; Class IIa, IIb and III mandatorily require a Notified Body-issued CE certificate. If you don't have one, we first need to initiate a CE certification process with a Notified Body — Medex guides this process as well.
How do I transfer ownership of an existing product to another company?
It is done via the "Ownership Transfer" workflow in ÜTS. Both transferor and transferee must be registered in ÜTS, a notarised transfer agreement must be uploaded, and TİTCK approval is required. Average duration: 7–14 business days.
Is EUDAMED registration different from ÜTS?
Yes. ÜTS is the national system run by TİTCK, while EUDAMED is the European Commission's EU-wide database. Sales in Türkiye require ÜTS; placing devices on the EU market requires EUDAMED. As of 28 May 2026, all EUDAMED modules will be mandatory.
📞 Get in Touch for Your ÜTS Registration
We build a tailored roadmap based on your device class, existing documentation and target market. Our initial consultation and proposal are completely free of charge.
📍 Ankara HQ: Ehlibeyt Mah. Tekstilciler Cad. No: 35/7, 06520 Çankaya / Ankara
📍 Istanbul Office: Cevizli Mah. Zuhal Cad. Ritim İstanbul B Blok No: 44, Maltepe / Istanbul
☎ +90 505 580 4622 | +90 312 389 1354
✉ medexkurumsal@gmail.com
Medex Corporate Consultancy — Regulatory Compliance, Market Access, Sustainable Trust.