If you're planning to manufacture, import, or distribute medical devices in Turkey, understanding the ÜTS (Ürün Takip Sistemi) registration process is absolutely essential. This comprehensive digital platform has become the backbone of medical device oversight in Turkey, and compliance with its requirements is non-negotiable for anyone entering the Turkish healthcare market.
What is ÜTS?
The Product Tracking System, known as ÜTS (Ürün Takip Sistemi), is a mandatory national database developed and managed by the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health. This digital platform ensures complete traceability of medical devices from the moment they enter the Turkish market until they reach the end-user.
Think of ÜTS as Turkey's answer to the EU's EUDAMED system—it provides transparency and accountability across the entire medical device supply chain. Every medical device that enters the Turkish market must be registered in this system before it can be sold or used.
Why Was ÜTS Implemented?
The implementation of ÜTS serves several critical purposes for Turkey's healthcare system:
Enhanced Traceability: The system tracks medical devices through every stage—production, importation, distribution, sales, and usage. This comprehensive tracking ensures that authorities always know where devices are in the supply chain.
Public Health Protection: By monitoring device safety and quality at every step, ÜTS helps protect patients and healthcare workers from substandard or counterfeit products.
Regulatory Compliance: The system facilitates oversight by regulatory authorities and healthcare institutions, making it easier to enforce safety standards and conduct inspections.
Market Surveillance: TİTCK actively uses ÜTS as a surveillance tool to monitor the market, manage product recalls when necessary, and track adverse events associated with medical devices.
Transparency: All information about devices in the market becomes accessible to authorized parties, reducing opportunities for fraud and improving accountability.
Who Must Register with ÜTS?
Registration with ÜTS is mandatory for several categories of stakeholders in the medical device supply chain:
Manufacturers: Companies producing medical devices within Turkey must register their facilities and products before placing them on the market.
Importers: Any company bringing medical devices into Turkey from abroad must complete ÜTS registration. Foreign companies cannot directly launch products in Turkey—they must work through a Turkish entity.
Distributors and Dealers: Companies involved in distributing and selling medical devices throughout Turkey must be registered and authorized as medical device sales centers.
Healthcare Institutions: Hospitals, clinics, and other healthcare facilities must use the ÜTS system to track the medical devices they purchase and use.
A critical point for international manufacturers: only Turkish entities can register products in ÜTS. If you're a foreign company, you'll need to establish a local presence through a Turkish affiliate, distributor, or authorized partner.
Key Prerequisites for ÜTS Registration
Before beginning the ÜTS registration process, companies must have several essential documents and certifications in order:
CE Certificate: Turkey's regulations are closely harmonized with EU standards. A valid CE mark from a recognized Notified Body is essential and demonstrates that your device meets high safety and performance standards. Without a CE certificate, ÜTS registration cannot proceed for medical devices.
ISO 13485 Certification: This quality management system certificate proves your organization has processes specifically designed for medical device production, covering everything from design and development to manufacturing and distribution.
Medical Device Sales Center Authorization: This document must be obtained from the Provincial Health Directorate and is required for any entity that will sell medical devices in Turkey.
Company Documentation: You'll need your MERSİS (Central Trade Registry System) number, tax certificate, and other official company documents.
Technical Documentation: This includes your Technical File, Declaration of Conformity, and any relevant product certificates. Documents in foreign languages must be translated into Turkish by sworn translators and notarized.
GTIN Number: The Global Trade Item Number allows products to be uniquely identified worldwide and is mandatory for product registration in ÜTS. You can obtain this from GS1 Turkey, with separate GTIN definitions required for each product variant.
The ÜTS Registration Process: Step by Step
The registration process involves two main phases: company registration and product registration.
Phase 1: Company Registration
First, your Turkish entity must register with the ÜTS system. Here's how it works:
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Access the System: Log into the Electronic Application System (EBS) using your e-Government password, e-signature, or mobile signature.
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Create Company Record: Navigate to the "My Company Applications" screen and create a new company record.
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Complete Information: Enter all required company details, including your MERSİS number and tax certificate information. Accuracy is critical—incorrect entries are one of the most common reasons for application delays.
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Upload Documentation: Submit all necessary documents, including your Medical Device Sales Center Authorization Certificate, Responsible Manager documentation, and Sales Promotion Personnel documents.
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E-Signature Approval: Sign the application electronically and submit it to TİTCK.
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Await Approval: TİTCK reviews your application. If all documents are complete and accurate, approval typically comes within a few business days.
Phase 2: Product Registration
Once your company is registered, you can begin registering individual medical devices:
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Prepare Product Information: Gather all device-specific information, including technical specifications, intended use, risk classification, and regulatory references.
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Document Upload: Enter your device information in the ÜTS portal, including the UDI-DI (Unique Device Identifier) for product line tracking. Upload your Technical File, Declaration of Conformity, CE certificates, and any other relevant documentation.
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Classification Confirmation: The registration requirement is determined by examining the product's definition, intended use, and regulatory classification. Even low-risk Class I devices require ÜTS registration in most cases.
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Batch Traceability: For disposable or single-use items, you'll focus on batch traceability and compliance documentation for factors like sterility and materials.
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Complex Device Registration: For more sophisticated devices with multiple configurations or accessories, you'll need to provide detailed technical specifications and may need to register multiple product variants.
The entire product notification process in ÜTS typically takes approximately one week, assuming all documentation is complete and accurate.
Common Challenges and How to Avoid Them
Based on experiences from companies navigating the ÜTS system, several common pitfalls can delay or derail your registration:
Incorrect Information Entry: Simple errors in entering MERSİS numbers, tax certificates, or other identifying information can cause significant delays. Double-check all entries before submission.
Missing or Invalid Documents: Ensure all required documents are not only present but also current and properly formatted. Expired certificates or improperly notarized translations will be rejected.
Underestimating Localization Requirements: Turkey has specific localization rules for documentation and labeling. Device labels must comply with ÜTS registration requirements, and all technical documentation must be available in Turkish.
Assuming CE Mark is Sufficient: While the CE mark is essential, it's only one piece of the puzzle. You still need to complete the full ÜTS registration process with all required Turkish-specific documentation.
Neglecting Ongoing Compliance: ÜTS registration isn't a one-time event. Your compliance efforts must continue after initial approval, as TİTCK uses the system for ongoing market surveillance.
The Role of Consultancy Services
Given the complexity of the ÜTS registration process, many companies choose to work with specialized consultancy firms. While not mandatory, professional consulting services can offer significant advantages:
- Expertise: Consultants familiar with TİTCK requirements can identify potential issues before they cause delays.
- Speed: Experienced consultants can typically complete the process more quickly than companies navigating it for the first time.
- Accuracy: Professional support reduces the risk of errors that could lead to rejection or resubmission.
- Language Support: Consultants can help with translation requirements and communication with Turkish authorities.
- Ongoing Support: Many firms offer continued assistance with updates, modifications, and regulatory changes.
However, companies should note that even with consulting support, they'll need a valid e-signature or mobile signature for the actual ÜTS applications—this cannot be delegated.
Life After Registration: Ongoing Obligations
Successful ÜTS registration is just the beginning. Companies must understand their ongoing obligations:
Record Maintenance: Medical device technical files must be kept for ten years, ensuring long-term traceability and accountability.
System Updates: Some information in ÜTS can be updated as needed, such as product details and stock quantities. However, certain changes may require a new application.
Regular Audits: Registered companies are subject to ongoing audits by TİTCK regarding the safety and effectiveness of their products.
Market Surveillance Compliance: Companies must respond promptly to any market surveillance activities, including providing information about adverse events or participating in product recalls if necessary.
Sales Center Compliance: Only entities authorized as medical device sales centers can sell medical devices in Turkey. Healthcare institutions and pharmacies cannot purchase or use devices that aren't properly registered in ÜTS.
Consequences of Non-Compliance
The importance of ÜTS registration cannot be overstated. The consequences of operating without proper registration are severe:
- Devices without ÜTS registration cannot legally be placed on the Turkish market
- Healthcare institutions and pharmacies cannot purchase or use unregistered devices
- Non-compliance may result in significant legal and financial penalties
- Companies found in violation may face bans on future registrations
- Products may be seized and removed from the market
The Bigger Picture: Turkey's Regulatory Alignment with the EU
Understanding ÜTS is part of a larger story about Turkey's healthcare regulatory environment. Over recent years, Turkey has worked diligently to harmonize its medical device standards with the European Union.
The Turkish Regulation on Medical Devices and the Regulation on Medical Devices for In Vitro Diagnosis have been prepared in full harmony with the EU's Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
Recent amendments to European regulations aimed at reducing supply risks have been quickly reflected in Turkish legislation—amendments made to EU regulations in March 2023 and July 2024 were incorporated into Turkish regulations in April 2023 and August 2024, respectively.
This close alignment means that companies already familiar with EU regulations will find many parallels in the Turkish system, though important local requirements like ÜTS registration remain distinctly Turkish.
Current State of the ÜTS System
Since the ÜTS Transfer Environment opened for use by medical device companies on January 1, 2017, the system has grown substantially. Initial data transferred from the Turkish National Database for Medical Devices (TİTUBB) included over 5,000 firms, 140,000 documents, and more than 4 million medical devices.
Today, the system continues to expand, with currently seven notified bodies authorized in Turkey. Remarkably, 92% of the more than 517,000 medical devices registered in the system have been certified domestically, with most falling into the Class IIa and IIb risk categories.
This demonstrates both the maturity of Turkey's medical device regulatory infrastructure and the significant market opportunity for companies willing to navigate the registration requirements properly.
Conclusion: Planning Your ÜTS Registration Strategy
Entering the Turkish medical device market requires careful planning and attention to regulatory detail. The ÜTS registration process, while comprehensive, is manageable when approached systematically with the right preparation.
Key takeaways for success:
- Start early and gather all required documentation before beginning the registration process
- Ensure your CE certification and quality management systems are in order
- Consider working with experienced local consultants, especially for your first registration
- Understand that ÜTS registration is ongoing, not a one-time event
- Stay informed about regulatory updates and changes to requirements
- Build strong relationships with your Turkish partners or distributors
Turkey's healthcare market offers significant opportunities for medical device companies, with a growing population, expanding healthcare infrastructure, and increasing demand for advanced medical technologies. By understanding and complying with ÜTS requirements, companies can position themselves for success in this dynamic and important market.
For the most current information and detailed guidance, companies should consult directly with TİTCK through the official website (www.titck.gov.tr) and consider engaging qualified regulatory consultants familiar with Turkish medical device regulations.
This blog post provides general information about ÜTS registration requirements in Turkey as of November 2025. Regulations may change, and companies should always verify current requirements with official sources before proceeding with registration.