Turkey TITCK Medical Device Registration Guide (2026): Complete Process, Fees, Timeline & Requirements

Overview of Turkey's Medical Device Market

Turkey is one of the largest and fastest-growing medical device markets bridging Europe and Asia. With a healthcare expenditure exceeding 5% of GDP and a population of over 85 million, Turkey represents a significant commercial opportunity for medical device manufacturers. The Turkish medical device market is estimated at approximately $3.5–4 billion and continues to grow driven by hospital modernization, universal health insurance coverage, and Turkey's position as a medical tourism hub.

Turkey has fully harmonized its medical device regulations with the European Union. Since 2021, Turkey's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) mirror EU MDR 2017/745 and EU IVDR 2017/746 respectively. This means manufacturers with CE-marked devices benefit from a streamlined registration pathway — but there are critical Turkey-specific requirements you must satisfy.

The regulatory authority is the Turkish Medicines and Medical Devices Agency (TITCK) — also known as TMMDA (Türkiye İlaç ve Tıbbi Cihaz Kurumu). TITCK regulates medical devices, IVDs, pharmaceuticals, and cosmetics under the Ministry of Health.

Regulatory Framework

Key Legislation

Regulation	Purpose	Alignment
Turkish Medical Device Regulation (MDR)	Governs all medical devices placed on the Turkish market	Mirrors EU MDR 2017/745
Turkish IVD Regulation (IVDR)	Governs all in vitro diagnostic devices	Mirrors EU IVDR 2017/746
Product Tracking System (ÜTS) Regulation	Mandates electronic registration and traceability of all devices	Turkey-specific
Medical Device Advertising Regulation	Controls promotion and advertising of medical devices	Turkey-specific
E-Invoicing for Medical Devices (2025–2026)	Requires electronic invoicing for pharma and medical device trade	Turkey-specific; pharmacies/opticians by October 2026

Regulatory Authority

TITCK (Turkish Medicines and Medical Devices Agency) is responsible for:

• Classification of medical devices
• Oversight of conformity assessment and notified bodies
• Administration of the ÜTS electronic registration system
• Vigilance and post-market surveillance
• Advertising controls and market surveillance
• Facility licensing through Provincial Health Directorates

Turkish Standards Institution (TSE) provides voluntary standards and testing services, and may serve as a notified body through designated conformity assessment bodies.

Device Classification

Turkey uses the same EU-aligned classification system for medical devices and IVDs:

Medical Devices

Class	Risk Level	Examples
Class I	Low risk	Bandages, non-invasive examination gloves, manual wheelchairs
Class IIa	Moderate risk	Hearing aids, surgical instruments, diagnostic ultrasound
Class IIb	Moderate to high risk	Ventilators, surgical lasers, implantable infusion pumps
Class III	High risk	Heart valves, hip implants, spinal fusion devices

IVD Devices

Class	Risk Level	Examples
Class A	Low risk	General laboratory reagents, specimen collection containers
Class B	Moderate risk	Pregnancy self-test devices, urine test strips
Class C	Moderate to high risk	Blood glucose meters, genetic screening tests
Class D	High risk	HIV blood screening, blood typing reagents

Classification follows the same rules as EU MDR Annex VIII (or IVDR Annex VIII for IVDs). Manufacturers self-classify their devices, but TITCK may challenge classifications during review.

The ÜTS (Product Tracking System)

The Ürün Takip Sistemi (ÜTS) is Turkey's centralized electronic registration and traceability platform. This is the core system through which all medical devices and economic operators must be registered before products can be placed on the Turkish market.

What Must Be Registered in ÜTS

• All medical devices and IVDs (every sellable unit)
• All economic operators: manufacturers, authorized representatives, importers, distributors
• UDI (Unique Device Identification) data for each device
• Labeling and IFU files
• Adverse event reports and field safety corrective actions

Key Features

• Full traceability: Links devices to UDI information, labeling, and registered economic operators
• Customs integration: ÜTS data supports customs controls at Turkish borders
• Vigilance support: Enables TITCK to track adverse events and manage recalls
• Mandatory before market placement: No device may be sold in Turkey without ÜTS registration
• Access via EBS: The ÜTS is accessed through the Electronic Application System (EBS) using an e-Government password, e-signature, or mobile signature — this cannot be delegated to third parties

Important: CE Marking Is Not Sufficient on Its Own

A common misunderstanding is that CE marking alone grants Turkish market access. It does not. While Turkey has harmonized its regulations with the EU MDR/IVDR and CE marking is a prerequisite, document registration through ÜTS is a separate regulatory process. Even CE-marked devices must complete the full ÜTS registration process with all Turkish-specific documentation, including Turkish-language IFU, local AR appointment, and UDI data upload. Think of CE marking as the qualification step — ÜTS registration is the market access step.

Authorized Representative Requirements

Who Needs an Authorized Representative?

Foreign manufacturers (those outside Turkey) must appoint a Turkish Authorized Representative (AR) to legally place devices on the Turkish market. This is mandatory regardless of whether the manufacturer is based in the EU or elsewhere.

Exception: Under the EU-Turkey Customs Union, EU-based manufacturers may be exempt from appointing a separate Turkish AR — they may use their existing EU-based structure. However, in practice, most EU manufacturers still appoint a local AR for practical reasons (Turkish language requirements, customs liaison, vigilance management).

AR Responsibilities

• Acts as the legally accountable party before TITCK
• Manages ÜTS registration of devices and economic operators
• Supports market surveillance activities
• Manages vigilance reporting and field safety corrective actions
• Maintains records traceability
• Facilitates communication with Turkish authorities

Other Economic Operators

Role	Requirement
Manufacturer	Holds CE marking and technical documentation; ensures UDI assignment; maintains PMS/PMCF/PSUR activities; provides Turkish IFU and labeling
Importer	Verifies CE marking, UDI, Turkish language compliance, and ÜTS registration before placing devices on market
Distributor	Maintains traceability records; supports recalls and incident reporting

Any change in economic operators requires new registration in ÜTS.

Registration Process

Prerequisites

Before starting registration, ensure:

1. Your device has CE marking from an EU Notified Body (or equivalent conformity assessment)
2. You hold a valid ISO 13485:2016 certificate for the manufacturing facility
3. You have prepared a complete technical file compliant with EU MDR/IVDR
4. You have a Declaration of Conformity with applicable safety and performance requirements

Step-by-Step Registration

Step 1 — Classify Your Device

Determine the risk class using EU MDR Annex VIII (or IVDR Annex VIII) classification rules. Turkey applies the same classification as the EU.

Step 2 — Appoint an Authorized Representative

If you are a foreign manufacturer, appoint a Turkish-based AR. The AR must be registered in ÜTS and hold a valid medical device business permit.

Step 3 — Register in MERSIS

The company (or its AR) must register in the Central Registration System (MERSIS) — Turkey's centralized business registry.

Step 4 — Prepare Your ÜTS Dossier

Compile the registration dossier including:

• EC certificate (CE marking)
• ISO 13485:2016 certificate
• Technical file (per EU MDR/IVDR requirements)
• Declaration of conformity
• Turkish-language labeling and IFU
• UDI information

Step 5 — Submit via ÜTS

Submit the electronic registration dossier through the ÜTS portal. Class I devices follow a simpler registration based mainly on the manufacturer's self-declaration. Higher-risk devices (Class IIa, IIb, III) require more detailed documentation and may undergo additional assessment by TITCK.

Step 6 — TITCK Review

TITCK reviews the dossier. For CE-marked devices, the process is typically administrative verification rather than a full technical review, since Turkey recognizes EU conformity assessment.

Step 7 — Registration Confirmation

Upon approval, the device is registered in ÜTS and may be legally placed on the Turkish market.

Labeling and Language Requirements

Language requirements in Turkey depend on the intended user:

Intended User	Label Requirement	IFU Requirement	On-Screen Interface
Professional-use devices	May be in English	Must be in Turkish	May be in English
Lay-person (consumer) devices	Must be in Turkish	Must be in Turkish	Must be in Turkish

UDI Requirements

UDI implementation is mandatory. Each sellable unit must be registered with a unique UDI-DI (GTIN/EAN) in ÜTS. Labeling files are uploaded as part of the registration process.

• Class III devices: UDI mandatory since implementation
• Class IIa/IIb devices: UDI mandatory
• Class I devices: UDI required per ÜTS registration rules

Registration Validity

Medical device registration in Turkey's ÜTS is valid indefinitely. Renewal is only required in cases of:

• Significant changes to the product
• Renewal of the EC certificate
• Regulatory changes requiring updated registration

This is a significant advantage over many countries that require periodic re-registration.

Fees and Timeline

Registration Timelines

Device Class	Typical Timeline	Review Type
Class I	A few weeks	Administrative verification
Class IIa/IIb	2–4 months	Administrative + limited review
Class III	3–6 months	More detailed review

These timelines assume a complete dossier with valid CE marking. Devices without CE marking or with incomplete documentation will face longer timelines.

Fee Estimates

Item	Estimated Cost
ÜTS registration (per device)	Minimal government fee
Authorized Representative fees (annual)	$3,000–$10,000
Regulatory consultant (dossier preparation)	$5,000–$20,000
Document translation (English to Turkish)	$1,000–$5,000
MERSIS registration	Minimal
Total estimated cost per device	$9,000–$35,000

Government fees for medical device registration are generally lower than for pharmaceutical products, where full MMA (Manufacturing Marketing Authorization) can cost TRY 100,000–500,000 (approximately $5,000–$25,000).

Post-Market Obligations

Vigilance and Adverse Event Reporting

Registration holders and other institutions have an obligation to notify TITCK if they learn or suspect that a product is defective. For medical devices, adverse event reporting follows the Turkish MDR vigilance requirements, which mirror EU MDR vigilance requirements.

Key obligations include:

• Serious incidents: Report to TITCK immediately upon becoming aware
• Field Safety Corrective Actions (FSCA): Report to TITCK before or at the time of implementation
• Periodic Safety Update Reports (PSUR): Required per EU MDR timelines
• Trend reporting: Report statistically significant increases in non-serious incidents

Supply Interruption Notification

TITCK requires manufacturers to notify the agency at least 6 months before any anticipated supply interruption or discontinuation of a medical device, unless the situation is unforeseeable. Failure to provide timely notification may result in enforcement action against the AR.

Post-Market Surveillance (PMS)

Manufacturers must maintain PMS plans and PMCF activities consistent with EU MDR requirements, as Turkey's regulations mirror the EU framework. TITCK performs unannounced audits — your technical documentation must be a living document that accurately reflects the device as currently manufactured. Any changes to design, materials, or manufacturing processes must be documented and validated promptly.

E-Invoicing Requirements (2025–2026)

Turkey's Revenue Administration has introduced mandatory e-invoicing for pharmaceutical and medical device trade:

• Medical device traders: Deadline was extended to December 1, 2025
• Pharmacies and opticians: Deadline is October 1, 2026

The Technical Guide specifies required fields and formatting standards for e-invoices in this sector. All taxpayers enrolled in the e-Invoice system who engage in pharmaceutical and medical device trade must comply.

Common Challenges and How to Avoid Them

1. Missing Turkish-Language IFU

Professional-use devices require Turkish IFU. Lay-person devices require Turkish labels, IFU, and on-screen interfaces. Prepare translations before starting registration.

2. Outdated CE Certificate

Turkey recognizes EU conformity assessment. If your CE certificate has expired or does not cover the device variant you want to register, your application will be delayed or rejected.

3. Incomplete ÜTS Registration

All economic operators and device data must be registered in ÜTS before market placement. Missing UDI data or incomplete labeling files will block registration.

4. Incorrect Product Classification

While Turkey uses the same EU classification rules, TITCK may challenge a classification. Ensure your classification rationale is well-documented and defensible.

5. AR Not Properly Registered

Your Authorized Representative must hold a valid medical device business permit and be properly registered in ÜTS. Verify your AR's credentials before engaging them.

6. Supply Interruption Non-Compliance

TITCK enforces the 6-month advance notification rule for supply interruptions. Ensure your AR agreement includes robust early-warning clauses.

Total Cost Estimate

Cost Item	Estimated Range
Government registration fees	Minimal (included in ÜTS)
Authorized Representative (annual)	$3,000–$10,000
Regulatory consultant (dossier preparation)	$5,000–$20,000
Turkish translation (IFU, labeling)	$1,000–$5,000
UDI implementation (if not already done)	$1,000–$5,000
Testing (if Turkey-specific testing required)	$2,000–$15,000
Total estimated cost per device	$12,000–$55,000

Key Takeaways

• Turkey mirrors EU MDR/IVDR — if you have CE marking, you benefit from a streamlined registration pathway
• ÜTS registration is mandatory before any device can be placed on the Turkish market
• Foreign manufacturers must appoint a Turkish Authorized Representative (with limited exceptions for EU manufacturers under the Customs Union)
• Registration is valid indefinitely — no periodic re-registration required
• Turkish-language IFU is mandatory for all devices; Turkish labels required for lay-person devices
• UDI is mandatory for all device classes registered in ÜTS
• Budget 2–6 months for registration depending on device class
• Budget $12,000–$55,000 total per device including all costs
• E-invoicing compliance required for medical device trade in Turkey
• Supply interruption notifications must be filed 6 months in advance

2026 Regulatory Updates You Should Know

TITCK 2026–2027 Compliance Action Plan

TITCK has released its 2026–2027 compliance action plan, which includes enhanced oversight of medical device registrations, increased scrutiny of ÜTS data quality, and new requirements for post-market surveillance documentation. Manufacturers should ensure their Turkish AR is aware of and complying with the latest TITCK communications.

Exclusion List Update (January 2026)

TITCK published updated guidance on which products are excluded from medical device regulations under the Turkish MDR and IVDR. The list clarifies boundaries for "borderline" products — items like hospital furniture, general-use textiles, medicated wipes, and dual-use laboratory equipment that should not be registered as medical devices in ÜTS. Misclassification can lead to regulatory audits and penalties.

Medical Device Software Regulation

TITCK has been developing guidance on medical device software (MDSW) classification and registration, aligned with EU MDR requirements. Manufacturers of SaMD products should monitor for updated TITCK guidance on software-specific registration requirements.

E-Prescription and Telehealth Expansion

Turkey continues to expand its digital health infrastructure, including e-prescriptions and remote monitoring via wearable medical devices. All stakeholders must obtain required permissions and licenses from the Ministry of Health. Data protection compliance under Turkish Personal Data Protection Authority (KVKK) is mandatory.

Frequently Asked Questions

How long does medical device registration take in Turkey?

Class I devices: a few weeks. Class IIa/IIb: 2–4 months. Class III: 3–6 months. These timelines assume CE-marked devices with complete documentation.

Do I need CE marking to register in Turkey?

Turkey has harmonized its regulations with EU MDR/IVDR. CE marking from an EU Notified Body is the primary basis for registration. Without CE marking, you may need to undergo a full conformity assessment through a TITCK-recognized Turkish notified body.

Is a local clinical trial required?

Not typically. Turkey accepts clinical data generated in EU member states and other recognized jurisdictions. Turkey is ICH-compliant, and clinical data from ICH-member countries is routinely accepted.

Can EU manufacturers sell in Turkey without an Authorized Representative?

Under the EU-Turkey Customs Union, EU manufacturers may have a simplified pathway, but in practice most still appoint a local AR for Turkish language compliance, customs liaison, and vigilance management.

What is ÜTS and why does it matter?

ÜTS (Ürün Takip Sistemi) is Turkey's centralized electronic registration and traceability system. All devices and economic operators must be registered in ÜTS before market placement. It provides full product lifecycle traceability from customs to end-user.

Is ISO 13485 mandatory?

Yes. A valid ISO 13485:2016 certificate for the manufacturing facility is a prerequisite for registration in ÜTS.

Does Turkey accept CSDT format?

Turkey follows EU MDR/IVDR format rather than ASEAN CSDT. However, technical documentation prepared for EU CE marking is directly applicable.

What are the post-market surveillance requirements?

Turkey mirrors EU MDR PMS requirements, including PSURs, PMCF plans, trend reporting, and vigilance reporting. All reports must be available to TITCK upon request.