MEDICAL DEVICE REGISTRATION ON ÜTS

Medical Device ÜTS Registration is the process of registering medical devices and related products in Turkey’s Ürün Takip Sistemi (ÜTS) (Product Tracking System). This system, developed by the Turkish Medicines and Medical Devices Agency (TİTCK), ensures traceability of medical devices from production to end-user.

What is ÜTS Registration?

The Product Tracking System (ÜTS) is a digital platform used to monitor the following stages of medical devices:

✅ Production
✅ Import
✅ Distribution
✅ Sales
✅ Usage

ÜTS registration is mandatory for manufacturers and importers, and it must be completed before placing devices on the market.

Who Needs to Register in ÜTS?

🏭 Manufacturers – Companies producing medical devices in Turkey.
🌍 Importers – Companies importing medical devices from abroad.
📦 Distributors & Dealers – Companies distributing and selling medical devices.
🏥 Healthcare Institutions – Organizations using medical devices and tracking them through ÜTS.

Purpose and Benefits of ÜTS Registration

✅ Traceability: Ensures tracking of medical devices at every stage, from production to the end-user.
✅ Public Health: Enhances the safety and quality of medical devices, protecting public health.
✅ Transparency: Makes all information about devices in the market accessible.
✅ Regulatory Compliance: Facilitates oversight by authorities and healthcare institutions.

What Happens If a Device is Not Registered in ÜTS?

🚫 Devices without ÜTS registration cannot be placed on the market.
🚫 Healthcare institutions and pharmacies cannot purchase or use unregistered devices.
🚫 Non-compliance may result in legal and financial penalties.

Key Considerations for ÜTS Registration

🔹 Ensure all required documents are complete and appropriate for the device classification.
🔹 Enter accurate and complete product details.
🔹 Device labels must comply with ÜTS registration requirements.