Ensuring Seamless Compliance for Turkey Medical Device Registration & Regulatory Landscape
Turkey has emerged as one of the fastest-growing medical device markets in the EMEA region, driven by expanding healthcare infrastructure, increasing demand for advanced medical technologies, and strong government investments in healthcare modernization. With its regulatory framework fully aligned to the European Union Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746), Turkey offers manufacturers a familiar yet strategically important market for regional expansion. To legally commercialize Medical Devices and IVDs in Turkey, manufacturers must obtain CE marking, comply with the applicable EU MDR/IVDR requirements, appoint a Turkey Local Representative (where applicable), and complete product registration or notification through the Product Tracking System (UTS), administered by the Turkish Medicines and Medical Devices Agency (TITCK).
Although Turkey follows the EU regulatory framework, market entry involves several country-specific requirements that manufacturers must address. Managing CE compliance alongside Turkish registration obligations, p reparing compliant technical documentation , maintaining Turkish-language labeling , coordinating UTS registrations, and fulfilling post-market surveillance responsibilities can significantly increase regulatory complexity. Manufacturers may also face challenges related to evolving TITCK requirements, local representation (If applicable), documentation consistency, customs clearance, and ongoing lifecycle compliance. Even minor gaps in regulatory submissions or registration records can result in approval delays, market access interruptions, product recalls, or increased compliance risks.
Freyr partners with global medical device manufacturers to simplify every stage of Turkey Medical Device Registration. From developing the right regulatory strategy and reviewing CE documentation to providing Turkey Local Representative services, managing UTS registrations, and supporting post-market compliance, our experts ensure your products meet both EU and Turkey-specific regulatory expectations. By combining deep knowledge of EU MDR/IVDR requirements with extensive experience in Turkey's regulatory landscape, Freyr helps manufacturers reduce approval timelines, minimize compliance risks, and achieve sustainable market access with confidence.
Freyr Medical Device Turkey Key Offerings
![Regulatory Strategy & Market Entry Consulting]()
Regulatory Strategy & Market Entry Consulting
Develop customized Regulatory strategies aligned with TITCK requirements and EU MDR/IVDR regulations.
![Medical Device Classification]()
Medical Device Classification
Support accurate classification of Medical Devices and IVDs under the applicable European regulations adopted by Turkey.
![Turkey Local Representative Services]()
Turkey Local Representative Services
Act as your trusted Regulatory partner by providing local representation and Regulatory communication support.
![UTS Registration & Product Notification]()
UTS Registration & Product Notification
Manage complete registration and product notification activities through Turkey's Product Tracking System (UTS).
![CE Technical Documentation Support]()
CE Technical Documentation Support
Prepare, review, remediate, and maintain Technical Files, Design Dossiers, Declarations of Conformity, and associated Regulatory documentation.
![EU MDR & IVDR Transition Support]()
EU MDR & IVDR Transition Support
Assist manufacturers transitioning legacy products to EU MDR and IVDR requirements applicable in Turkey.
![Clinical & Performance Evaluation]()
Clinical & Performance Evaluation
Develop Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Risk Management Files, and Biological Evaluation Reports.
![Labeling & Translation Compliance]()
Labeling & Translation Compliance
Ensure labels, Instructions for Use (IFUs), packaging, and Regulatory documentation meet Turkish language and labeling requirements.
![Quality Management System Support]()
Quality Management System Support
Provide ISO 13485 implementation, gap assessments, audit preparation, and ongoing compliance support.
![Post-Market Surveillance]()
Post-Market Surveillance
Support vigilance reporting, Field Safety Corrective Actions (FSCAs), complaint handling, Regulatory updates, and lifecycle maintenance.
Freyr Medical Device Turkey Key Offerings
Turkey Local Representative (TLR) Service Offerings
Local Regulatory Representation
Serve as your authorized point of contact with TITCK for Regulatory communications and submissions.
UTS Registration Management
Coordinate device registration, updates, product notifications, and lifecycle management within the UTS platform.
Regulatory Documentation Review
Verify compliance of Technical Documentation, CE Certificates, Declarations of Conformity, labeling, and supporting files.
Authority Communication
Respond to Regulatory queries, deficiency requests, inspections, and product- related communications from TITCK.
Vigilance & Incident Reporting
Coordinate post-market safety reporting, recalls, adverse event notifications, and corrective actions.
Audit & Inspection Readiness
Prepare manufacturers for Regulatory inspections by ensuring documentation and compliance records remain inspection-ready.
Book a meeting with our experts today
- Schedule a call today
Why Partner with Freyr ?
- End-to-end Turkey Medical Device Registration support
- Strong expertise in EU MDR and IVDR compliance adopted by Turkey
- Experienced Regulatory professionals with global and regional knowledge
- Complete UTS registration and lifecycle management support
- Turkey Local Representative services for international manufacturers
- Comprehensive Technical Documentation and CE compliance expertise
- End-to-end support from Regulatory strategy through post-market surveillance
- Proven experience accelerating market access while minimizing Regulatory risk
Frequently Asked Questions (FAQs)
01. Which authority regulates medical devices in Turkey?
Medical devices and in vitro diagnostic devices in Turkey are regulated by the Turkish Medicines and Medical Devices Agency (TITCK). TITCK oversees product registration, market surveillance, post-market compliance, and enforcement activities. Manufacturers must comply with TITCK requirements before commercializing devices in Turkey.
02. Do medical devices require CE marking before they can be sold in Turkey?
Yes. Turkey has harmonized its medical device legislation with the European Union's MDR (EU 2017/745) and IVDR (EU 2017/746). As a result, CE marking is a mandatory prerequisite for placing most medical devices and IVDs on the Turkish market. The conformity assessment must be completed through the appropriate Notified Body where required.
03. What is the Product Tracking System (UTS), and why is it important?
The Product Tracking System (UTS) is Turkey's national electronic platform used to register, monitor, and trace medical devices throughout their lifecycle. Manufacturers or their authorized representatives must register applicable products in UTS before commercialization. The platform also supports traceability, post-market surveillance, and regulatory oversight.
04. How are medical devices classified in Turkey?
Turkey follows the same classification system established under the EU MDR and IVDR.
For medical devices, classifications include Class I, IIa, IIb, and III based on the level of patient risk.
For IVDs, products are classified into Classes A, B, C, and D according to their intended purpose and associated risk.
The device classification determines the applicable conformity assessment procedure and documentation requirements.
05. What documentation is typically required for Turkey Medical Device Registration?
Documentation requirements generally include CE Certificates (where applicable), Declaration of Conformity, Technical File or Design Dossier, ISO 13485 certification, Risk Management documentation, Clinical Evaluation or Performance Evaluation Reports, labeling, Instructions for Use (IFUs), and Turkish translations where required. Additional documentation may be requested depending on the device type and classification.
06. How long does the Turkey Medical Device Registration process take?
The registration timeline varies depending on the device classification, completeness of technical documentation, CE certification status, and responsiveness during Regulatory review. For CE-marked devices with complete documentation, registration through UTS can often be completed within approximately two to six months, although timelines may vary based on individual circumstances.
07. What post-market obligations must manufacturers fulfil after registration?
Manufacturers are responsible for maintaining ongoing compliance after commercialization. This includes vigilance reporting, adverse event management, Field Safety Corrective Actions (FSCAs), complaint handling, updating product information in UTS, maintaining technical documentation, implementing post-market surveillance activities, and ensuring continued compliance with applicable Regulatory requirements.
08. Why choose Freyr for Turkey Medical Device Registration?
Freyr provides comprehensive support across the entire product lifecycle, including Regulatory strategy, device classification, CE documentation review, Turkey Local Representative services, UTS registration, labeling compliance, ISO 13485 consulting, post-market surveillance, and Regulatory lifecycle management. With extensive experience supporting global manufacturers across multiple markets, Freyr helps accelerate approvals, reduce compliance risks, and enable sustainable market access in Turkey.
