UTS Product Registration for Medical Devices

UTS Product Registration

UTS (Urun Takip Sistemi, the Turkish Product Tracking System for medical devices) records each product against the company that places it on the market. Without a valid product record, the device cannot be legally sold, reimbursed, or submitted to hospital tenders in Turkey. A correct product record depends on the identifying information entered at the time of registration.

Core Information Entered Against Each Product

• Product definition and classification (GMDN code, risk class, intended use)
• All regulatory documents for the product
• Product images and photographs showing the device as supplied
• Technical specifications including dimensions and performance characteristics
• Measurement data where the device is measuring
• Storage and handling conditions

Product Identification

UTS identifies each product through a barcode system, typically a GS1 barcode issued against the manufacturer's GS1 company prefix. The barcode binds the physical unit to the regulatory record and supports traceability if a recall is required.

CE Documentation

The CE mark label, the CE product certificate (EC certificate) issued by the notified body, and the manufacturer's declaration of conformity must all be entered in UTS. These three documents together demonstrate that the product has passed the conformity assessment route required by its directive and risk class.

Trademark and Branding

UTS requires the product's trademark information, including a brand declaration, and a visual representation of how the mark appears on the labelling. For manufacturers without a registered Turkish trademark, filing through TURKPATENT (the Turkish Patent and Trademark Office) is a parallel track we often run alongside the UTS registration.

Product Name and Version

The product name must be stated clearly in Turkish, with international technical classification names alongside where applicable. The product version, model code, and associated supporting documents must be entered, so that different model variants are tracked independently.

Why Accuracy at Entry Matters

An inaccurate product record at registration propagates into reimbursement files, hospital procurement records, and post-market surveillance. Correcting a registered UTS record is slower than preparing the record correctly the first time. The technical file, the catalogue, and the IFU should all reconcile before the upload.

How Sistem Patent Kalite Helps

Sistem Patent Kalite has served Turkish and international manufacturers since 1999. Our team reviews the technical file, assigns the correct GMDN codes, coordinates GS1 barcode allocation, prepares the Turkish-language IFU and catalogue, and runs the UTS product entry under the company's authorised electronic signature. Contact us for UTS product registration or for any question about the Turkish medical device market.