Turkey UTS Registration: Legal Basis Guide V4.0

1. Key takeaways

For any manufacturer preparing to place medical devices on the Turkish market, understanding the legal architecture behind ÜTS — the Ulusal Ürün Takip Sistemi, the national product tracking system — is the starting point of compliance planning. The points below set out the statutory anchors, the operative guidance layer and the breadth of the obligated parties, all of which shape how registration work must be organised.

• The parent provision of ÜTS is Madde 34, paragraph 1, of the Medical Device Regulation: without prejudice to the EUDAMED obligations contained in the Regulation, economic operators established in the country, notified bodies, healthcare institutions, healthcare professionals and other relevant persons must all fulfil the ÜTS-related obligations.
• Paragraph 2 of Madde 34 is the design source of ÜTS duties: the specific obligations under ÜTS are determined by normative documents issued by the Kurum. This is the legal basis on which the operating layer can iterate to V4.0 without amending the Regulation itself.
• On 13 May 2026, TİTCK issued the Tıbbi Cihazların Ürün Takip Sistemine Kayıt Süreçlerine İlişkin Kılavuz — the Guide on Registration Processes in the Product Tracking System for Medical Devices. The issuing department is the Department of Medical Device Registration and Coordination (Tıbbi Cihaz Kayıt ve Koordinasyon Daire Başkanlığı), and the official document is marked as version V4.0.
• The scope of Madde 34 is extremely broad and is not limited to the licence holder in the registration sense: importers, healthcare institutions and healthcare professionals are all among the obligated parties. This means that stock movement reporting at the hospital end constitutes a statutory action at the far end of the supply chain.

2. Legal basis

The table below consolidates the instruments cited in this article, pairing each with its Turkish title, its official reference and publication date, and the specific provisions on which the analysis rests. Reading the instruments in this order — parent Regulation first, then the operational guide — reflects how the obligation chain is actually constructed.

3. Expert insights

Insight one: ÜTS is the national layer within a landscape of coexisting dual obligations. Madde 33 carries the European database obligations on the EUDAMED side, while Madde 34 carries the national ÜTS obligations; the two provisions run in parallel and do not replace each other. The simplest way to grasp this point is that Madde 33 faces Europe while Madde 34 faces Turkey. Companies that treat the two systems as alternatives — doing the EUDAMED work and assuming the national duty is thereby discharged — misread the structure at its foundation. Every data submission, every traceability exercise and every reporting routine has to be mapped to both layers separately, because each rests on its own provision, its own authority and its own cycle of updates.

Insight two: the way V4.0 was iterated reveals the rhythm of regulatory enforcement. This registration process guide was issued through a TİTCK announcement, and the document itself carries a version number (V4.0); a single version switch replaces the registration operating guidance that preceded it. Enterprises that in 2026 are still working from an earlier version of the operating instructions are carrying internal control documents that have already expired. GRZAN recommends treating a version switch as a trigger-based review event rather than waiting until the quarterly review to discover it. The practical lesson is that the operative layer moves faster than the statutory layer, and internal document control must be tuned to that speed.

Insight three: by writing hospitals into the obligated parties, Madde 34 changes the direction of data flow. The Regulation expressly lists healthcare institutions (sağlık kuruluşları) and healthcare professionals (sağlık meslek mensupları) among the subjects of ÜTS obligations. For export enterprises, the practical implication is that the point of use and consumption at the end user is not a black box: the reporting actions of distributors and customer hospitals will back-check whether a supplier’s outbound records are consistent. A discrepancy flagged at the hospital end can therefore surface at the supplier’s desk, and record-keeping discipline must be built with that reverse verification in mind from the outset.

4. Practical recommendations

• Immediately verify whether internal operating instructions are based on the V4.0 version issued on 2026-05-13; if they rest on an earlier version, update them after a version comparison and retrain the relevant staff.
• For projects holding stock or distribution in Turkey, designate the responsible person for reporting inbound and outbound movements, returns and scrapping, and write the question of whether the distributor has reported into the monthly reconciliation.
• State in contracts with local partners that where either party’s ÜTS reporting error results in the product being restricted in circulation, that party bears the corresponding responsibility.

5. Verification checklist

• □ Madde 34, paragraphs 1 and 2, have been cited as the legal basis of ÜTS.
• □ The registration process guide issued on 2026-05-13 (V4.0) has been obtained and filed.
• □ The scope of obligated parties has been confirmed to cover importers, healthcare institutions and healthcare professionals.
• □ The version of internal operating instructions has been checked and updated.
• □ A monthly reconciliation action for distributor ÜTS reporting has been established.

Regulatory information verified to 29 October 2026. The parent provisions listed in this article were checked against the original text on the Turkish legislative information system (MevzuatNo 38657); the issue date, issuing department and version marking of the registration process guide were taken from the announcement page on the TİTCK website and from the official document itself. The announcement dated 2024-10-07 has no visible Official Gazette number and is handled as a practical estimate.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team prepares CE/UTS-compliant documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com