Turkey Medical Device Market Access: TITCK, UTS and CE Marking Three-Layer Structure

1. Key takeaways

Market access for medical devices in Turkey is built on a three-layer superimposed structure: a regulatory authority layer (TİTCK), a product conformity layer (CE marking, Madde 20) and a national registration and traceability layer (ÜTS, Madde 34). When any one of the three layers is absent, the product may not circulate lawfully in Turkey. The points below summarise how the layers interact and why this structure matters for export planning.

• Turkey’s device access model is a three-layer superimposed structure: the regulatory authority layer (TİTCK), the product conformity layer (CE marking, Madde 20) and the national registration and traceability layer (ÜTS, Madde 34). With any one of the three layers absent, the product may not circulate lawfully in Turkey.
• The CE marking answers the question of whether the product is conforming; ÜTS answers the question of whether this product is traceable in Turkey. The two operate in parallel and cannot substitute for each other: Madde 24 provides that devices conforming to the requirements of the Regulation shall not be refused, prohibited or restricted from being placed on the market, while Madde 34 at the same time provides that economic operators within the territory, notified bodies, healthcare institutions and health professionals must discharge their ÜTS obligations.
• The specific content of ÜTS obligations is determined by normative documents issued separately by TİTCK (Madde 34 paragraph 2). This is the legal foundation on which the operational layer can iterate to new versions without amending the Regulation itself.
• The most recent official document on the ÜTS registration process is the Guide on the ÜTS Registration Processes for Medical Devices (V4.0), published on 13 May 2026 by the TİTCK Medical Device Registration and Coordination Unit.
• GRZAN’s assessment: equating ÜTS with a registration certificate is a common misjudgment. It is closer to a combination of a one-time product registration plus a full lifecycle inventory movement reporting duty, and the coming into effect of a registration does not mean the end of responsibilities.

2. Legal basis

The instruments below constitute the legal foundation of the three-layer structure described in this article. Each entry lists the official Turkish name of the instrument, its official gazette reference or issuing authority, the publication date and the specific articles on which the three-layer analysis relies. When building a regulatory file for the Turkish market, these four entries should appear as the primary citation set for authority, conformity marking and traceability obligations alike.

3. Expert insights

Insight 1: why Turkey has no independent device registration certificate. The institutional design of the device Regulation is organised around two main lines, conformity (uygunluk) and registration (kayıt), and it does not set up a separate national technical review and certificate issuance stage for products that already hold a CE certificate. Conformity assessment is carried by the European notified body system, while Turkey carries the administrative compliance registration and the traceability duty. This is a structural difference from the system shapes found in Russia, Brazil and China. GRZAN insists that, in multi-country pathway planning run in parallel, this distinction is made first, so that the registration logic of an applicable country is not mistakenly transposed onto Turkey.

Insight 2: Madde 34 paragraph 2 is an open-ended authorisation. This paragraph states expressly that ÜTS obligations are determined by the provisions issued by the Kurum. It means that TİTCK can change the operational practice without invoking the amendment procedure of the Regulation. This is precisely the legal basis on which the ÜTS registration guide was able to iterate to V4.0, and it is also the reason why monitoring TİTCK announcements must become a routine part of a company’s regulatory work. In its services, GRZAN maintains official regulation texts and institutional guidance as two separate monitoring levels, so that changes at the operational layer are not missed while attention stays fixed on the Regulation alone.

Insight 3: Madde 20 and Madde 24 form an obligation and right pairing. Madde 20 sets out the formal and timing requirements of the CE marking (affixed to the device or to the packaging that keeps it sterile, to each instruction for use and to each sales package, completed before placing on the market; where a notified body is involved, its identification number must follow the CE marking). Madde 24 then grants the corresponding market access right. For export companies the practical meaning of this pairing is that, as long as the CE certificate chain is complete and the ÜTS obligations are discharged, the local regulatory stage has no room for discretionary refusal; conversely, once the ÜTS side is missing, the protection of Madde 24 does not apply automatically.

4. Practical recommendations

• At the project initiation stage, run a three-layer self-check first: whether the TİTCK entity qualification has been established, whether the CE certificate chain is valid and covers the models intended for export, and whether the ÜTS entity registration and product registration have been completed. If any one of the three layers is missing, commercial shipments should not be started.
• Include changes at the guide level in a quarterly review item. The Regulation itself has undergone three amendments since 2021-06-02, on 2022-07-29 (Sayı 31907), 2023-04-02 (Sayı 32151) and 2024-08-17 (Sayı 32635), while changes at the ÜTS operational layer occur more frequently than amendments to the Regulation.
• When signing agreements with Turkish local partners, define explicitly which party maintains the ÜTS registration. If the responsibility for registration information and for inventory movement reporting is not divided in the contract, any break in the chain will place responsibility first on the registration obligor listed in the register.
• Distinguish one-time investment from annual maintenance at the quotation stage. In comparable projects GRZAN usually prices the long-term reporting duty of ÜTS as a separate item, so that clients do not misjudge it as a one-off buy-out.

5. Verification checklist

• □ Check the notified body identification number on the CE certificate and confirm that it is valid within the certificate period and covers the target models (Madde 20 paragraph 5).
• □ Check that the CE marking has been affixed according to the pattern in Ek V to the device or its sterile packaging, to the instruction for use and to the sales packaging (Madde 20 paragraphs 1, 3 and 4).
• □ Confirm that ÜTS entity registration and product registration are completed, and that the registration obligor matches the party actually supplying the goods (Madde 34).
• □ Confirm that the 2026-05-13 V4.0 registration process guide has been obtained and that internal work instructions have been updated accordingly.
• □ Confirm the language versions required for documents issued by the Turkish counterpart, and assign responsibility for the language of labels, instructions for use and sales packaging to a named person (subject to the case-by-case reply of TİTCK; practical estimate).

Regulatory information verified as of 29 October 2026. The regulation names, official gazette issue numbers, publication dates and article numbers listed in this article were checked against the Turkish Official Gazette (Resmî Gazete), the Turkish Legislation Information System (Mevzuat Bilgi Sistemi, MevzuatNo 38657) and public information of the Turkish Medicines and Medical Devices Agency (TİTCK). Periods and operational details for which the official original text has not been obtained are marked as 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 manages TITCK registrations aligned with the EU MDR/IVDR framework, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com