UTS Registration in Turkey for Medical Devices

ÜTS (Ürün Takip Sistemi, the Product Tracking System of the Turkish Medicines and Medical Devices Agency, TİTCK) is the central database in which medical devices and cosmetic products are registered and followed from production or import to the end user. For a foreign manufacturer the practical meaning is simple: a medical device that is not registered in ÜTS cannot be placed on the Turkish market. The CE marking is the basis of the registration, but it does not replace it.

For ÜTS registration, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

What a foreign manufacturer needs to know

• Registration is made by a company established in Turkey: normally your importer or distributor, or your own Turkish subsidiary.
• That company must first hold a medical device sales centre authorisation from the provincial health directorate. Without it, TİTCK does not accept the company registration.
• The authorisation in turn requires a trained responsible manager and at least one qualified sales and promotion representative.
• The manufacturer supplies the conformity documents. Their quality decides how quickly the product registration is completed.

What ÜTS is for

• Recording all medical devices on the market
• Tracing registered products through the supply chain
• Supporting market surveillance and inspections
• Allowing fast action against a risk arising from a product
• Withdrawing unsafe products from the market and from use quickly
• Preventing counterfeit and non-compliant products and identifying the companies authorised to sell

Two stages: company and product

Product registration is not possible until company registration is complete.

Documents requested for medical devices

• CE certificate, where a notified body is involved, with the details of that body
• EU Declaration of Conformity
• Instructions for use
• Quality management system certificate (ISO 13485), where available
• Authorisation letter from the manufacturer to the importer or distributor
• Product catalogue and label information
• Technical file and test reports, on request

CE marking comes first

Turkey applies medical device regulations aligned with the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. A device cannot be registered in ÜTS without valid CE documentation.

• Class I devices: the manufacturer draws up its own Declaration of Conformity. Sterile devices, devices with a measuring function and reusable surgical instruments in Class I need a notified body for those aspects.
• Class IIa, IIb and III devices: a certificate from a notified body is required.

If your device does not yet carry the CE marking, that work has to be finished before the registration can start. See CE marking, medical device testing and the technical file.

Cosmetic products

ÜTS is also used for cosmetic products. Cosmetics do not carry the CE marking, so their registration follows the cosmetics legislation and not the medical device rules.

Checking a registration

A registered product or company can be searched in the ÜTS application portal of TİTCK by barcode, GTIN, company tax number or product name. A limited search is also available through the e-Government portal. GTIN is one of the formats that carries the UDI-DI of a medical device, so the code on your label and the code in ÜTS must match.

ÜTS and import

ÜTS registration and import clearance are two separate steps, and the CE documentation is the basis of both. For the customs side of CE-marked products see TAREKS import inspection in Turkey.

How CE Danışmanı helps

• Checking whether your CE documents are sufficient for registration
• Guiding your importer or distributor through the sales centre authorisation
• Company, document and product registration in ÜTS
• Notifications and updates when products, documents or certificates change