What You Want to Know About ÜTS Medical Device Registration and DMO Processes
Yes. In Türkiye, it is a legal obligation for all companies that manufacture or import medical devices, and for the distributors that sell these devices, to register with the Product Tracking System (ÜTS) under the Ministry of Health. Products without a registration cannot be sold, invoiced or supplied to public hospitals. For details, you can review our ÜTS Company Registration service.
The process varies according to your certification status (EC certificate, etc.) and your product variety. If your documents are complete, your company registration and distributor registration are completed within 1-2 weeks on average. ÜTS product registrations may take several weeks depending on the review times of TİTCK (the Turkish Medicines and Medical Devices Agency).
To be able to import, your company must first be registered in ÜTS. After that, technical documents such as the authorisation certificate, CE certificate and Declaration of Conformity obtained from the manufacturer abroad must be uploaded to the system. We manage this entire demanding process and the regulatory consultancy with our professional team.
The State Supply Office (DMO) Health Market is an official platform where public hospitals procure their medical devices and consumables. If you include your products in this system by making a DMO Catalogue Application, you gain the opportunity to sell directly to state hospitals across Türkiye without entering complex tender processes.
Yes. Private dental clinics, polyclinics and dentists' practices are obliged to make a supply notification for the devices they purchase and a consumption notification (stock deduction) for the materials they use on patients, via ÜTS. These transactions are required for product traceability (UDI).
Absolutely. Under the new TİTCK regulatory arrangements, the use of the Product Tracking System by dental prosthetics laboratories has become a legal obligation. Laboratories must regularly make incoming-outgoing notifications for all consumables they use, such as zirconium, porcelain powder and implant parts. You can review our Corporate ÜTS Training tailored for laboratories.
Yes. In Ministry of Health and TİTCK audits, administrative fines are imposed on businesses (including dentists, laboratories and distributors) that fail to register products and that do not make stock and consumption notifications on time. In the case of repeated violations, legal sanctions extending up to the suspension of activity are possible.
EUDAMED is the European Union's central database for medical devices (MDR/IVDR). Use of the system's first four modules became mandatory on 28 May 2026. Manufacturers, authorised representatives and importers must first obtain an SRN (Single Registration Number) through actor registration. We provide end-to-end EUDAMED consultancy throughout your company's actor registration process.