UTS Company Registration for Medical Device Firms in Turkey

What UTS Is

UTS (Urun Takip Sistemi, the Product Tracking System) is the Turkish Ministry of Health database that records every company and every product active in the medical device supply chain in Turkey. It is the national equivalent of the device traceability systems required by the EU medical device directives covering general medical devices, active implantable medical devices, and in vitro diagnostic medical devices.

Who Must Register

Every legal entity that places medical devices on the Turkish market or distributes them must be registered in UTS. This includes:

• Manufacturers producing medical devices in Turkey
• Importers bringing CE-marked medical devices into Turkey
• Authorised representatives acting for foreign manufacturers
• Distributors, dealers, and supply-chain intermediaries
• Pharmacies, hospitals, and service providers that sell or deploy devices

Electronic Signature Is Mandatory

UTS company registration is performed online, and the legal representative must complete the registration using a qualified electronic signature (e-imza). The electronic signature binds the company's regulatory declarations to a named individual, and that individual is accountable for what is filed afterwards.

Documents Typically Required

The exact list of documents depends on the company type (manufacturer, importer, distributor). The core set includes trade registry records, tax records, signatory authorisation for the UTS user, and for importers and authorised representatives the contract with the foreign manufacturer. Once the company record is approved, product records can be added against it.

How Sistem Patent Kalite Helps

Sistem Patent Kalite has worked on UTS company registration since the system was introduced. Our team reviews the company structure, prepares the required documents, runs the electronic signature steps with the legal representative, and handles clarification requests from the Ministry of Health if the first submission needs revision. With offices in Turkey and partners abroad, we serve both domestic firms and foreign manufacturers entering the Turkish market.

Contact Us

For UTS company registration, authorised representative setup, or any related question, contact our specialists.