Turkey TİTCK Medical Device Registration & ÜTS Portal Consultant
Navigate Turkey's TİTCK regulatory framework with confidence. NexorTest Technologies provides end-to-end medical device registration consulting — from device classification and CE marking through ÜTS portal registration and sales center authorization — for Class I through Class III devices, IVDs, and SaMD.
Four Risk-Based Device Classes Under Turkish MDR
Turkey classifies medical devices identically to EU MDR 2017/745, using the same 22 classification rules from Annex VIII. Your device class determines the regulatory pathway, Notified Body requirements, and registration timeline.
Class I Devices
Lowest-risk devices including bandages, stethoscopes, wheelchairs, and reusable instruments. Non-sterile, non-measuring Class I devices require only manufacturer self-declaration of conformity.
- 2-4 Weeks
- Self-Declaration
- DoC
How is Class I different in Turkey?
Class I non-sterile, non-measuring devices require only manufacturer self-declaration of conformity. Class I sterile or measuring devices need NB involvement for those specific aspects. All must register on ÜTS.
Class IIa Devices
Low-moderate risk devices such as hearing aids, blood transfusion sets, dental materials, and diagnostic ultrasound equipment. Requires Notified Body certification and ÜTS registration.
- 3-6 Months
- Notified Body
- ÜTS Registration
What testing is needed for Class IIa?
Requires Notified Body quality system audit, performance testing, Essential Principles compliance, ISO 13485 certification, and Turkish-language labeling. CE certificate must be valid.
Class IIb Devices
Moderate-high risk devices including ventilators, X-ray machines, insulin pumps, surgical lasers, and anesthesia machines. Requires Notified Body certification with clinical data.
- 6-9 Months
- NB Certification
- Clinical Data
Is clinical data required for Class IIb?
Yes. Class IIb devices require clinical evaluation demonstrating safety and performance per EU MDR Article 61. This may include clinical investigation data, published literature, or equivalence-based evidence.
Class III Devices
Highest-risk devices including cardiac stents, pacemakers, hip implants, drug-eluting stents, and heart valves. Subject to full Notified Body audit and comprehensive clinical evaluation.
- 9-18 Months
- Full NB Audit
- Clinical Evaluation
Do Class III devices need clinical trials in Turkey?
Class III devices require comprehensive clinical evaluation. Clinical investigations may be needed if existing data is insufficient. TİTCK and Ethics Committee approval is required for clinical investigations conducted in Turkey.
Comprehensive TİTCK Registration Services
From initial classification through post-market surveillance, NexorTest manages every aspect of your Turkish medical device regulatory journey.
TİTCK Device Registration
End-to-end registration with TİTCK for all device classes. ÜTS product notification, document upload, TİTCK review management, and UTS barcode assignment for full supply chain traceability in the Turkish market.
ÜTS Portal Management
Expert management of Turkey's Product Tracking System including company registration, product notification, document uploads, and barcode tracking from production to end-user. Qualified personnel compliance since January 2025.
CE Marking for Turkey Market
CE marking preparation and Notified Body coordination. Turkey accepts CE certificates from EU-recognized NBs under the EU-Turkey Customs Union. We manage the entire certification process for Turkish market entry.
Technical File Preparation (Turkish)
Complete technical documentation including Turkish-language labels, IFU translation, Declaration of Conformity (Uygunluk Beyanı), and Essential Principles checklist per Turkish MDR requirements for all device classes.
ISO 13485 QMS Implementation
Full ISO 13485:2016 Quality Management System implementation, gap analysis, documentation development, internal audit support, and certification body coordination for TİTCK regulatory compliance.
Clinical Evaluation Reports
Clinical evaluation planning and report preparation per EU MDR Article 61. Literature reviews, equivalence arguments, and clinical investigation support for all device classes entering the Turkish market.
IVD Registration Turkey
In Vitro Diagnostic device registration under Turkish IVDR. Classification (Class A-D), performance evaluation, Notified Body coordination, and ÜTS submission aligned with EU IVDR 2017/746 requirements.
SaMD Regulatory Pathway Turkey
Software as Medical Device regulatory strategy. Classification per Rule 11, IEC 62304 lifecycle documentation, cybersecurity assessment, and AI/ML device guidance for the Turkish medical device market.
Post-Market Surveillance & Vigilance
PMS systems, PSURs for Class IIa/IIb/III, serious incident reporting to TİTCK, Field Safety Corrective Actions, and ongoing ÜTS compliance monitoring for continued market access in Turkey.
Turkey's Trusted TİTCK Specialist
We combine deep Turkish regulatory expertise with global experience to deliver faster, more predictable TİTCK registrations and ÜTS approvals.
Turkey & EU Dual Regulatory Expertise
Deep understanding of both Turkish TİTCK requirements and EU MDR framework. Turkey's regulations mirror EU MDR 2017/745, but ÜTS and sales center requirements add Turkey-specific complexity we navigate daily.
Design + Testing + Certification Under One Roof
Integrated services covering product design review, safety testing at accredited labs, and complete regulatory certification — eliminating multi-vendor complexity for Turkish market entry.
ÜTS Portal Specialists
Dedicated team experienced with Turkey's Product Tracking System including qualified personnel requirements (mandatory since Jan 2025), technical service commitments, and sales center authorizations.
Multi-Region Regulatory Expertise
Simultaneous registrations across TİTCK, US FDA, EU MDR/CE, CDSCO India, Saudi SFDA, and 30+ markets. One partner for global market access from a single integrated program.
Transparent Pricing & Fixed-Fee Packages
No hidden costs. Fixed-fee packages covering strategy through ÜTS registration, with clear milestones and deliverables at every stage of the Turkish registration process.
Six Steps to Your TİTCK Registration
A proven, structured approach that minimizes review queries and accelerates your path to the Turkish medical device market.
Device Classification & Regulatory Strategy
We determine your device’s risk class per EU MDR-aligned Turkish rules (22 classification rules from Annex VIII). We develop a regulatory strategy including applicable standards and the optimal pathway for Turkish market entry.
CE Marking & Notified Body Coordination
We prepare technical documentation and coordinate with EU or Turkish Notified Bodies. CE certificates from EU-recognized NBs are accepted in Turkey under the EU-Turkey Customs Union, streamlining the certification process.
Technical Documentation & Turkish Labeling
Our team completes the technical file, Declaration of Conformity, Essential Principles checklist, and Turkish-language labels and IFU translation per TİTCK requirements for all device classes.
ÜTS Portal Registration
We register your company in ÜTS, submit product notification with all documents, manage TİTCK review, and obtain your ÜTS barcode for full supply chain traceability from production to end-user in Turkey.
TİTCK Review & Sales Authorization
We navigate the TİTCK review process, resolve queries promptly, and obtain sales center authorization certificate (Tıbbi Cihaz Satış Merkezi Yetki Belgesi) for legal distribution of your device throughout Turkey.
Market Launch & Post-Market Compliance
We support your device launch in Turkey, establish PMS systems, vigilance reporting, PSUR preparation, technical service commitment registration, and ongoing ÜTS compliance to maintain your market access.
TİTCK Registration Across All Device Sectors
NexorTest supports medical device manufacturers across every therapeutic area and technology vertical entering the Turkish market.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
TİTCK Registration FAQ
Expert answers to the most common questions about medical device registration with TİTCK in Turkey.
What is TiTCK medical device registration in Turkey?
TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) is Turkey’s Medicines and Medical Devices Agency under the Ministry of Health. All medical devices marketed in Turkey must be registered through TİTCK’s ÜTS (Product Tracking System). Turkey’s Medical Device Regulation, published 2 June 2021, is aligned with EU MDR 2017/745, requiring CE marking as a prerequisite for market entry. The process involves device classification, CE certification, ÜTS registration, and obtaining sales center authorization.
Is CE marking accepted in Turkey?
What is the ÜTS product tracking system?
ÜTS (Ürün Takip Sistemi) is Turkey’s mandatory electronic product tracking system managed by TİTCK. All medical devices must be registered in ÜTS before being marketed. The system tracks devices from production to end-user through unique barcodes. Since January 2025, only qualified personnel can register devices in ÜTS, and technical service commitments must be registered. ÜTS is independent of the EU’s EUDAMED system.
How are medical devices classified in Turkey?
Turkey follows the identical classification system as EU MDR 2017/745, using the same 22 classification rules from Annex VIII. Devices are classified into Class I (low risk), Class IIa (medium risk), Class IIb (medium-high risk), and Class III (high risk) based on invasiveness, duration of contact, intended use, and active/non-active nature. Software (SaMD) is classified under Rule 11 based on clinical condition severity.
What documents are required for TiTCK registration?
Required documents include: valid CE Certificate (for Class IIa/IIb/III) or Declaration of Conformity (Class I), ISO 13485:2016 certificate, technical file/design dossier, Declaration of Conformity (Uygunluk Beyanı), labels and IFU in Turkish, Free Sale Certificate, clinical evaluation report, letter of authorization for local representative, and UDI information. All documents must be uploaded to the ÜTS portal.
How long does medical device registration take in Turkey?
ÜTS registration timelines depend on device class and documentation completeness. Class I devices typically take 2-4 weeks. Class IIa and IIb devices take 3-6 months including Notified Body certification. Class III devices may take 6-15 months with full clinical evaluation. The ÜTS notification itself can be approved in approximately 1 week once all documents are in order. NexorTest helps ensure complete submissions for faster processing.
Does Turkey require Turkish-language labeling?
Yes. Turkish-language labeling is mandatory for all medical devices. Labels and Instructions for Use (IFU) must be in Turkish. Professional-use devices may include additional EU languages alongside Turkish, but Turkish must always be present. Universal symbols per harmonized standards (e.g., ISO 15223) may be exempt from translation. NexorTest manages complete Turkish translation and labeling compliance.
Can NexorTest help with IVD and SaMD registration in Turkey?
Yes. NexorTest provides specialized registration services for IVDs and SaMD in Turkey. For IVDs, Turkey’s IVDR regulation (aligned with EU IVDR 2017/746) classifies devices into Class A-D with phased transition deadlines: Class D by May 2025, Class C by May 2026, Class B by May 2027. For SaMD, we handle Rule 11 classification, IEC 62304 documentation, cybersecurity assessments, and AI/ML device regulatory strategy.
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Expand Beyond Turkey with Multi-Market Access
Leverage NexorTest's global regulatory network to register your medical device in 30+ markets from a single integrated program.
US FDA 510(k)
EU MDR CE Marking
EU IVDR
UK UKCA / MHRA
Saudi SFDA
UAE MoHAP
TGA Australia