Medical device registration in Türkiye is often described as “EU-aligned, so straightforward for European manufacturers.” The alignment is real. The straightforward part is not. EU MDR compliance is the entry prerequisite, not the process itself. On top of it sits a Turkish-specific registration layer, a national product tracking system, reimbursement mechanics that run on a separate clock, and a series of 2024-2026 regulatory updates that many market-entry guides have not yet caught up with.
This article covers what the registration process actually involves, in the sequence it actually runs, with the timeline that actually applies.
The Regulatory Authority and Its Operating Logic
TİTCK: Structure and Mandate
The Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu, TİTCK) is the national competent authority for all medical devices and IVDs. It sits within the Ministry of Health and governs the full product lifecycle: pre-market notification, post-market surveillance, vigilance, recall management, and enforcement.
TİTCK mirrors the European Medicines Agency in structural logic but operates with its own procedural timelines, language requirements, and administrative workflows. Understanding this is the first calibration required: EU experience accelerates the process, but does not replace it.
How Türkiye Aligns with EU Regulation
Türkiye transposed EU MDR 2017/745 and IVDR 2017/746 into national law on 2 June 2021 (Official Gazette No. 31499). The transposition is near-verbatim. Subsequent EU regulations follow within 6 to 12 months:
- EU Regulation 2023/607 on extended transitional periods: transposed 2 April 2023
- EU Regulation 2024/1860 on supply continuity and shortage obligations: transposed 17 August 2024, via Articles 10/A and 11/A
The Gün and Partners regulatory update provides a detailed account of these amendments. The practical consequence: if it is required in Brussels, it will be required in Ankara within 6 to 12 months. This dynamic alignment is a feature of the system, not a temporary transition state.
The ÜTS System: What It Is and How It Works
The National Device Registry
The Ürün Takip Sistemi (ÜTS) is Türkiye’s national medical device tracking system, equivalent in function to EUDAMED. No device can be legally placed on the Turkish market without ÜTS registration, regardless of CE marking status. As of 2023, ÜTS holds 517,944 registered products, with 478,246 (92%) certified by Turkish notified bodies.
ÜTS is not purely an administrative filing system. It is a live, end-to-end traceability platform integrated with SGK’s Medula reimbursement system, the Hospital Information Management System, and at least 15 other national databases. A product’s ÜTS registration status determines its operational eligibility across all public hospital and tender systems.
What ÜTS Registration Requires in Practice
ÜTS registration is fee-free. The cost lies in the preparation, not the filing. The platform requires:
- Device data: classification, description, intended purpose, risk class
- UDI/GTIN: unique device identification, mandatory for all classes
- Turkish-language labelling and IFU (uploaded as part of the dossier)
- Economic operator details (see Section 4 below)
- Technical file reference (not always uploaded in full, but must be available on request)
- ISO 13485:2016 certificate
From 1 January 2025, only certified responsible managers may file ÜTS registrations on behalf of an economic operator. This is a 2024 regulatory update that distributors and local partners need to have actioned. Verify that your Turkish economic operator has qualified personnel in place before proceeding.
Device Classification
The Risk Class Framework
Türkiye uses the same four-class framework as the EU MDR and IVDR. Classification rules are identical:
| Class | Risk level | Examples | ÜTS review |
|---|---|---|---|
| Class I | Low | Bandages, non-sterile instruments, stethoscopes | Streamlined; 2 to 4 weeks |
| Class IIa | Medium-low | Hearing aids, dental fillings, short-term implants | Notified body certificate required |
| Class IIb | Medium-high | Infusion pumps, X-ray equipment, ventilators | Full technical file, notified body involvement |
| Class III | High | Heart valves, coronary stents, neurostimulators | Intensive pre-market review; 3 to 6 months |
IVDs follow IVDR classification (A, B, C, D). Class C and D IVDs require Turkish notified body involvement.
Why Classification Matters Beyond Compliance
Risk class determines not only the registration pathway but also the SUT reimbursement category, the tender eligibility framework, and, from 2026, the committee approval rules added by the January 2026 SUT update for high-risk orthopaedic and cardiovascular implants. Classify early and verify against both MDR annexes and TİTCK’s national classification guidance, which contains a small number of Turkish-specific adjustments.
The Authorised Representative Question: Correcting a Common Misconception
What EU Manufacturers Actually Need
There is a persistent error in market-entry guides that deserves direct correction. Many sources state that all foreign manufacturers must appoint a Turkish authorised representative. This is inaccurate for EU-based manufacturers.
The European Commission’s March 2022 Notice to Stakeholders on the EU-Türkiye Customs Union Agreement in the field of medical devices confirms:
- EU-based manufacturers are exempt from designating an authorised representative in Türkiye
- Turkish manufacturers are reciprocally exempt from designating an EU authorised representative
- CE certificates from EU notified bodies are accepted in Türkiye without re-examination
- Turkish notified body certificates are accepted in the EU
- Manufacturers based outside both the EU and Türkiye must designate one authorised representative, in either jurisdiction
What EU Manufacturers Do Need
The exemption from AR designation does not mean you can operate without a local entity. EU manufacturers need a Turkish-established economic operator authorised by the Ministry of Health as a “medical device sales centre.” This entity is responsible for ÜTS registration, post-market reporting, supply continuity notifications, and physical sales operations. It can be a manufacturer affiliate, a distributor, or a dedicated local partner.
This distinction shapes how the relationship is contractually structured. An AR agreement implies the representative holds your regulatory status. A sales centre agreement implies a commercial and operational mandate. The two carry different liabilities and different exit mechanisms. Get the structure right before signing anything.
For manufacturers based outside both the EU and Türkiye: a formal AR designation is required, and the AR must be registered in ÜTS with the same obligations as an EU economic operator.
Documentation Requirements
The Technical File
The technical file for Turkish registration follows MDR structure. TİTCK does not require the full file to be uploaded to ÜTS at notification stage, but it must be available on request, in Turkish, within a defined response window. For Class IIb and III devices, TİTCK may require submission of specific sections during review.
Core technical file components:
- Device description and intended purpose
- Risk analysis and risk management summary (ISO 14971)
- Clinical evaluation report or performance evaluation (IVDs)
- Essential requirements / general safety and performance checklist
- Post-market surveillance plan
- CE certificate reference
Labelling and Turkish IFU
Turkish-language labelling and Instructions for Use are mandatory for all device classes without exception. Requirements per The Other Consultants’ Turkey regulatory guide:
- INCI or equivalent ingredient/component identification where applicable
- Turkish warnings, contraindications, and usage instructions
- Manufacturer name and address (Turkish address for the economic operator)
- UDI/GTIN barcode
Translation must be performed by a qualified translator and reviewed against the source IFU for consistency. Discrepancies between original and translated content are a primary source of TİTCK clarification requests and timeline delays.
UDI and Serialisation Requirements
UDI is mandatory across all device classes and must be registered in ÜTS as part of the notification. From October 2025, distributors are required to include GTIN, batch number, and serialisation data in e-invoices. Pharmacies follow from October 2026. This aligns Turkish invoicing traceability with EUDAMED-equivalent standards and adds a compliance step that the economic operator and distribution chain must have operationally integrated.
ISO 13485
ISO 13485:2016 certification is required for ÜTS registration and is verified by Turkish notified bodies. It is not optional for any device class. For manufacturers already holding ISO 13485 from a recognised certification body, the certificate transfers directly.
The Registration Process: Step by Step
Step 1. Classify the device and confirm scope
Verify risk class under Turkish MDR/IVDR rules. Confirm whether your CE certificate covers the intended Turkish indication. Flag any Turkish-specific classification adjustments.
Step 2. Confirm and contract the Turkish economic operator
This is the foundational commercial decision. The economic operator holds your ÜTS registration, carries post-market obligations, and is your legal interface with TİTCK. Selection criteria must include regulatory qualification (certified responsible manager as of January 2025), financial resilience (public hospital DSO runs to 16 to 36 months in some channels), and channel alignment with your commercial targets.
Step 3. Prepare the Turkish technical file and IFU
Adapt the existing MDR technical file for Turkish submission requirements. Commission Turkish-language IFU and labelling translation. Review for consistency. This step is typically run in parallel with Steps 2 and 4.
Step 4. Prepare the ÜTS dossier
Compile all ÜTS-required data: device classification, UDI/GTIN, economic operator details, CE certificate, ISO 13485, Turkish IFU, labelling samples. Verify that the economic operator’s responsible manager certification is current.
Step 5. Submit the ÜTS product notification
The notification is submitted by the economic operator through the ÜTS portal. For Class I devices, the review is administrative and typically completes in 2 to 4 weeks. For Class IIa, IIb, and III, TİTCK conducts a substantive review and may issue clarification requests. Response timelines for clarification requests are fixed and must be met to avoid dossier suspension.
Step 6. SGK SUT code application (run in parallel with Steps 3 to 5)
If public hospital reimbursement is a commercial objective, the SGK SUT listing process must begin as early as possible. It is independent of ÜTS registration and runs on its own administrative calendar. SUT listing takes 6 to 18 months for established categories and 12 to 24 months for novel devices. Running it sequentially after registration adds a year to the commercial timeline.
Step 7. Post-registration compliance setup
Once registered, the economic operator must maintain ÜTS registration, file periodic post-market surveillance updates, report serious incidents to TİTCK within defined windows, and manage supply continuity notifications under Articles 10/A and 11/A where applicable.
Timeline and Cost Expectations
Realistic Timelines by Device Class
| Stage | Class I | Class IIa/IIb | Class III |
|---|---|---|---|
| Economic operator contracting | 6 to 10 weeks | 6 to 10 weeks | 6 to 10 weeks |
| Turkish IFU and labelling | 4 to 6 weeks | 4 to 6 weeks | 4 to 6 weeks |
| ÜTS dossier preparation | 2 to 4 weeks | 4 to 8 weeks | 6 to 10 weeks |
| TİTCK review and registration | 2 to 4 weeks | 3 to 6 months | 3 to 6 months |
| SGK SUT application (parallel) | N/A or 3 to 6 months | 6 to 18 months | 12 to 24 months |
| First private hospital revenue | 3 to 5 months | 6 to 12 months | 9 to 14 months |
| First public hospital revenue | 6 to 12 months | 12 to 18 months | 18 to 30 months |
Cost Structure
ÜTS registration itself carries no fee. Total project costs include: Turkish IFU and technical file translation (typically TRY 10,000 to 50,000 depending on volume and class), notified body fees where a new Turkish certificate is required, economic operator setup and first-year representation, and any remediation of technical file gaps identified during review.
Meddeviceguide’s 2026 Turkey registration guide cites a range of USD 9,000 to 35,000 per registration. This is a reasonable order-of-magnitude for planning purposes, with Class I at the lower end and Class III with full SUT support at the higher end.
Key Regulatory Updates: 2024 to 2026
Articles 10/A and 11/A: Supply Continuity Obligations
Transposed 17 August 2024, with a facilitative transition period to 31 December 2025. From 2026, economic operators must proactively notify TİTCK of anticipated supply disruptions within defined windows. A comprehensive TİTCK guideline was expected during 2025. Per RegDesk, the framework mirrors EU Regulation 2024/1860 in both scope and reporting obligations.
Qualified Personnel Requirement
Effective 1 January 2025. Only certified responsible managers may register devices on ÜTS on behalf of a Turkish economic operator. This is not a transitional requirement. Any distributor or local partner that has not ensured their responsible manager certification is current is operating with a compliance gap.
E-Invoicing with GTIN and Serialisation
Distributors: effective 1 October 2025. Pharmacies: 1 October 2026. All invoices in the distribution chain must include GTIN, batch number, and serialisation data. This aligns Turkish traceability with EUDAMED-equivalent standards and requires integration between the economic operator’s ERP and ÜTS.
SUT Update January 2026
New device codes added with clearer committee approval requirements for high-risk cardiovascular implants, orthopaedic implants, and spine devices. Updates across Annex 2, 3, and 4 also affect cardiology, gastroenterology, and dental procedure reimbursement. Per MedDeviceGuide, manufacturers with pending SUT applications in these categories should review their submissions against the updated framework.
IVD-Specific Considerations
IVDR Transposition and Classification
IVDs are regulated under the Turkish IVDR framework, transposed alongside MDR in June 2021. The four-class system (A through D) mirrors EU IVDR classification rules. Class C and D IVDs require Turkish notified body involvement. Anatolia Geneworks, the first Turkish manufacturer to obtain IVDR certification (May 2024, via QMD Services), set the precedent for domestic compliance with the new framework.
Performance Data and Turkish Labelling
IVD submissions require clinical and analytical performance data adapted to Turkish population and clinical practice context where relevant. Turkish-language labelling must include not only translation of the original IFU but also Turkish-specific warnings and reagent descriptions where the language of biochemistry diverges from the EU standard.
ÜTS Integration for IVD Reagents
IVD reagents and kits require separate ÜTS notification from the instruments they run on. Reagent shelf-life, lot coding, and barcode formats must all conform to ÜTS technical specifications. The most common delay in IVD registration is not the clinical evidence section. It is the ÜTS technical integration of reagent data.
Post-Market Obligations
Vigilance Reporting
Serious incidents must be reported to TİTCK within defined post-market windows, mirroring EU MDR timeframes: 15 days for unexpected events not constituting a serious deterioration in health, 10 days for serious deteriorations, 2 days for events posing immediate serious risk. The economic operator carries this obligation in practice.
Post-Market Surveillance Plan
The PMS plan must be maintained and updated at each periodic safety update report (PSUR) cycle. TİTCK aligns its PSUR expectations with MDR Article 86 (Class IIb, III) and Article 85 (Class IIa) cadences.
Supply Continuity Notifications
Under Articles 10/A and 11/A (in force August 2024), economic operators must notify TİTCK in advance of anticipated supply interruptions. The notification window, grace periods, and reporting format are governed by TİTCK’s implementing guidance, expected in final form during 2025. Operators should be monitoring the TİTCK regulatory calendar for the official publication.
Final Assessment
Medical device registration in Türkiye is not a bureaucratic exercise with a predictable end date. It is a multi-workstream project that begins with economic operator selection and ends only when post-market obligations are embedded into operational routine. The regulatory framework is genuinely aligned with the EU, and that alignment is a material advantage for European manufacturers over non-EU competitors. But the advantage accrues only to companies that start the Turkish registration and SGK SUT processes in parallel, not in sequence.
The companies that navigate this well treat ÜTS registration, SUT listing, Turkish IFU adaptation, and economic operator setup as four workstreams that begin simultaneously. The companies that struggle treat registration as a precondition to everything else, arrive at their first tender cycle without reimbursement coverage, and lose 12 to 18 months.
If you are preparing a Turkish registration project or reviewing an in-progress one, reach out to discuss the specific requirements for your device class and commercial objectives.
Frequently Asked Questions
What is TİTCK and what does it regulate?
TİTCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) is the Turkish Medicines and Medical Devices Agency, the national competent authority within the Ministry of Health. It governs the full medical device and IVD lifecycle in Türkiye: pre-market notification, post-market surveillance, vigilance reporting, recall management, advertising, and distribution authorisation. All medical device registrations pass through TİTCK and the ÜTS national tracking system.
Is CE marking sufficient for the Turkish market?
CE marking is a prerequisite, not the process. Türkiye has transposed EU MDR 2017/745 and IVDR 2017/746, and CE certificates from EU notified bodies are accepted. However, a separate ÜTS product notification is mandatory regardless of CE status, Turkish-language IFU and labelling are required, a Turkish-established economic operator must be in place, and SGK SUT listing is needed for any public hospital reimbursement. CE marking opens the door. Registration is what happens after you walk through it.
Do EU manufacturers need a Turkish authorised representative?
No. Under the EU-Türkiye Customs Union Agreement, EU-based manufacturers are exempt from designating a Turkish authorised representative. The European Commission confirmed this in its March 2022 Notice to Stakeholders. What EU manufacturers do need is a Turkish-established economic operator authorised as a “medical device sales centre” to file on ÜTS and to sell in market. Manufacturers based outside both the EU and Türkiye must appoint a formal AR in one jurisdiction.
How long does ÜTS registration take?
For Class I devices: 2 to 4 weeks from a complete dossier submission. For Class IIa and IIb: 3 to 6 months including TİTCK review and possible clarification rounds. For Class III: 3 to 6 months for the registration itself, with first public hospital revenue typically 18 to 30 months from project start when SGK SUT listing is included. Total project timelines depend heavily on whether regulatory and reimbursement workstreams run in parallel from week one.
What is the SGK SUT system and why does it matter for registration planning?
SGK (Sosyal Güvenlik Kurumu) is the single public payer covering around 95% of the Turkish population. The SUT (Sağlık Uygulama Tebliği) is the reimbursement rulebook: it lists which device codes are covered at which tariffs. Without a SUT code and a barcode match with your device’s UDI in SGK’s Medula system, the device cannot be reimbursed in public hospitals. SUT listing runs on its own administrative calendar (typically two to three application windows per year) and takes 6 to 24 months depending on device category. It must be started in parallel with ÜTS registration, not after it.
What changed in the Turkish regulatory framework in 2024 and 2025?
Three changes require attention. First, Articles 10/A and 11/A on supply continuity were transposed in August 2024: economic operators must proactively notify TİTCK of anticipated supply disruptions, with transition arrangements running through December 2025. Second, from January 2025, only certified responsible managers may file ÜTS registrations on behalf of economic operators. Third, from October 2025, distributors must include GTIN, batch number, and serialisation data in all e-invoices, aligning Turkish distribution traceability with EUDAMED standards.