Importing CE-Marked Sterile Devices Into Turkey: TİTCK and ÜTS Steps

What does CE marking settle before a Turkish launch?

Consider a Turkish distributor preparing to import individually sterile-packed, CE-marked urology consumables from a foreign manufacturer. The supplier shares a CE certificate or declaration of conformity and asks for an initial purchase order, while the distributor states that its company is already active in the national portal. Both statements describe real prerequisites, yet neither answers whether the specific models are ready to clear Turkish customs and be placed on the market.¹²¹²

Turkey aligns its core non-IVD medical-device framework with European Union rules under the Turkish Medical Device Regulation (Tıbbi Cihaz Yönetmeliği), published in the Official Gazette on 2 June 2021 (No. 31499 mükerrer, with consolidated amendments displayed through 17 August 2024).¹⁶ Do not treat this framework as a newly enacted 2026 statute, and do not assume that European alignment eliminates national Turkish operator, registration, or border-control steps.¹⁶

The Republic of Türkiye Ministry of Trade's sectoral product-rules guidance identifies CE marking as the mandatory conformity mark for medical devices under the regulation.⁶ In that overview, ordinary Class I devices follow the manufacturer's declaration of conformity route without a notified body, whereas higher-risk devices follow the applicable Annex IX–XI conformity assessment procedures.⁶ For sterile single-use consumables, buyers should not infer from a high-level summary that CE notified-body involvement begins only at Class IIa: Class I devices placed on the market in sterile condition, having a measuring function, or supplied as reusable surgical instruments require notified-body involvement for their relevant limited aspects, and the actual product class and conformity route must always be verified from the manufacturer's current conformity file.²⁶ Before initiating any national filing in Turkey, distributor quality teams should review the CE certificate due-diligence context—confirming the issuing notified body's designation scope, certificate status, and exact model coverage.

Even after the underlying CE documentation is confirmed, Article 34 of the Turkish Medical Device Regulation expressly preserves national registration and notification obligations in the Product Tracking System (Ürün Takip Sistemi, ÜTS) administered by the Turkish Medicines and Medical Devices Agency (Türkiye İlaç ve Tıbbi Cihaz Kurumu, TİTCK), without prejudice to EUDAMED obligations.¹ Neither a valid CE mark nor an EUDAMED entry substitutes for completing the national ÜTS layers.¹

English-language legal and commercial guides already explain the broad sequence from CE conformity to ÜTS registration and customs clearance—Global Law Experts outlines the end-to-end launch stages, and Bıçak Law Firm notes that ÜTS registration functions as a regulatory tracking and market-surveillance record rather than a standalone clinical safety approval.⁷⁹ At the same time, commercial country tables such as MedTech Atlas explicitly disclose that their verification is incomplete while presenting generalized claims about local representation, fixed five-year registration validity, or class-based import permits.⁸ To make a defensible launch decision, a distributor or supplier-quality lead needs the provision-linked distinctions that sit across separate Turkish instruments: who holds each legal role, who is qualified to register devices in ÜTS, which document rules depend on risk class and conformity regime, and when a shipment triggers Ministry of Trade import inspection.¹²¹⁰¹²

Who is the authorized representative, importer and ÜTS filer?

A recurring failure mode in cross-border negotiations is using the phrase "Turkish representative" or "local registration holder" to describe three different functions at once. Before drafting a distribution contract or letter of authorization, separate four operational roles under the Turkish rules.¹¹⁰

1. Foreign legal manufacturer (İmalatçı): The natural or legal person responsible for designing, manufacturing, packaging and labeling the device under its own name and holding the CE declaration of conformity and applicable notified-body certificates.¹²
2. Authorized representative (Yetkili Temsilci): Under Article 3(1)(lll) of the Turkish Medical Device Regulation (reviewed in the consolidated legislative text), an authorized representative is defined as a natural or legal person established in Türkiye or in a European Union Member State who has received and accepted a written mandate from a manufacturer established outside Türkiye and the EU to act on the manufacturer's behalf for specified tasks.¹ Article 11(1) requires a written mandate where the manufacturer has no registered place of business in Türkiye or an EU Member State.¹ Accordingly, do not assume every non-Turkish manufacturer must appoint a separately Turkish-established authorized representative if an eligible EU representative mandate is in place—and equally, never assume that an EU authorized representative can perform the local duties of a Turkish importer or ÜTS filer.¹²
3. Turkish importer and licensed sales center (İthalatçı / Tıbbi Cihaz Satış Merkezi): Under Article 13 of the Turkish Medical Device Regulation, the importer placing a device on the market must verify that the device bears the CE mark, that the EU declaration of conformity has been drawn up, that the manufacturer is identified and has designated an authorized representative where applicable, that required accompanying information is provided, and that applicable UDI obligations are met.¹ Article 13 also requires the importer to indicate its name, registered trade name or trademark, registered place of business and contact address on the device, its packaging or an accompanying document without obscuring manufacturer information, and to ensure that storage and transport conditions do not jeopardize conformity.¹ In commercial practice, a Turkish firm registering in ÜTS as a producer, importer, dealer or exporter must also hold the required medical-device sales-center authorization recorded in the Ministry of Health's Core Resource Management System (Çekirdek Kaynak Yönetim Sistemi, ÇKYS).²¹⁰
4. Qualified ÜTS device-registration filer vs. routine movement notifier: Even inside a licensed Turkish importing firm, not every portal user has the same authority. TİTCK's sales-center guidance distinguishes the personnel qualified to submit initial device registrations in ÜTS from staff handling routine movement notifications for already registered products.¹⁰

Keeping these four roles distinct prevents two opposite commercial errors: rejecting an otherwise compliant foreign manufacturer file because its authorized representative is established in the EU rather than Istanbul, or assuming that an EU representative listed on the pouch can submit Turkish importer registrations and customs declarations.¹²

Which sales-center and personnel evidence should the buyer verify?

Before sending controlled technical files to a prospective Turkish importer, verify both the partner's facility authorization and the qualification of the individual who will register the devices in ÜTS. TİTCK's implementing guideline Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliğinin Uygulanmasına İlişkin Kılavuz (TCS-KLVZ-08 Rev.04, revised 30 December 2024) sets out the operational rules for sales centers and their certified personnel.¹⁰

Under Article 11(3) and 11(4) of TCS-KLVZ-08 Rev.04, device registration operations in ÜTS on behalf of a firm are subject to a specific personnel qualification rule effective from 1 January 2025.¹⁰ Buyers and distributors must read the three parts of that rule together rather than relying on an oversimplified summary:¹⁰

• The 1 January 2025 registration-personnel rule and the SM/STE/KDE exception: Article 11(3)–(4) provides that from 1 January 2025, ÜTS device registrations must be performed by qualified Medical Device Registration Personnel (Tıbbi Cihaz Kayıt Elemanı, TCKE). However, individuals who have completed the training and passed the examination for a Responsible Manager (Sorumlu Müdür, SM), Sales and Promotion Staff (Satış ve Tanıtım Elemanı, STE), or Clinical Support Staff (Klinik Destek Elemanı, KDE) qualification certificate are exempt from completing a separate TCKE training course and examination in order to obtain the registration qualification.¹⁰ Do not tell a distributor that every staff member needs an additional standalone TCKE course if an eligible SM, STE, or KDE qualification route has been properly completed and registered.¹⁰
• The own-working-center limitation: Article 11(4) specifies that personnel using the SM/STE/KDE exception and holding a working certificate at a medical-device sales center perform device registrations only for that center (kendi çalıştıkları merkez).¹⁰ A qualification certificate held by an individual working at another company does not grant an open-ended license to file device registrations for unrelated Turkish importers.¹⁰
• Routine movement notifications treated separately: Article 11(3) expressly distinguishes routine product-movement notifications (alma/verme bildirimleri—receiving and delivery notifications in ÜTS for already registered devices) from the device-registration training requirement.¹⁰ This operational distinction allows warehouse or logistics staff to record receipt and dispatch notifications for registered stock without holding the registration-filer qualification, while preserving all system-access, traceability, and regulatory notification obligations.¹⁰

When screening a prospective Turkish partner, request documentary proof from two official operational channels. First, the Ministry of Health provides an authenticated online service on e-Devlet—Tıbbi Cihaz Yeterlilik Belgesi Başvurusu—for medical-device personnel qualification certificate applications.⁵ Second, provincial health directorates administer sales-center licensing and personnel changes at the local operational level. For example, the Bingöl Provincial Health Directorate's official Tıbbi Cihaz Satış Merkezi İşlemleri page (updated 15 October 2026) publishes distinct application pathways and petition templates for initial sales-center opening, ownership transfer, address relocation, company title or address changes, and personnel additions or departures, while instructing applicants to confirm current supporting-document lists with the relevant unit.⁴ Treat provincial pages as operational evidence of how local health directorates process center and personnel files, not as a nationwide fee schedule or fixed approval timeline.⁴

Finally, verify that the partner's sales-center authorization is currently active. Under Article 11(5) of TCS-KLVZ-08 Rev.04, temporary suspension or permanent closure of a medical-device sales center restricts the center's ability to perform ÜTS registration and notification operations.¹⁰ A historical PDF of a sales-center certificate does not prove that the firm's ÇKYS and ÜTS permissions remain unrestricted today.²¹⁰

How should firm, document and device records be reconciled?

TİTCK's current registration guideline—Tıbbi Cihazların Ürün Takip Sistemine Kayıt Süreçlerine İlişkin Kılavuz (TCKKD-KLVZ-03, dated 13 May 2026 and distributed by provincial health directorates on 3 June 2026)—governs how firms, conformity documents, and medical devices are recorded in ÜTS.² Rather than imposing a single flat checklist on every product, TCKKD-KLVZ-03 structures registration into three linked layers—firm registration (firma kaydı), document registration (belge kaydı), and device registration (cihaz kaydı)—and separates legacy directive pathways from EU MDR/IVDR pathways.²

Check implementation before selecting a document route. Article 69(1)(a) makes Articles 8, 12 and 15, together with Article 39(4), effective with the ÜTS version update that makes their procedures technically functional. The other provisions take effect on publication under Article 69(1)(b).² This condition affects the imported-certificate and declaration branches below, including the physical-petition change in Articles 8(6) and 12(4). Have the qualified filer confirm the relevant update and current TİTCK submission instructions before choosing authentication, translation or electronic-only submission steps. This review does not establish when that update became operational; publication alone is insufficient evidence.

A scoped review of the operative provisions in TCKKD-KLVZ-03 (Articles 5, 8, 12(1)–(2) and (7), 17, 18, and 66) shows five verification branches that international suppliers and Turkish distributors must reconcile before filing:²

1. Firm identity (MERSİS/VEDOP) versus sales-center licensing (ÇKYS)

Under Article 5(1)–(2) and 5(5) of TCKKD-KLVZ-03, a company's base identity data in ÜTS is pulled from the Central Registry Record System (MERSİS) or the Tax Office Automation Project (VEDOP), with MERSİS taking priority where records exist in both systems.² However, identity registration is only the first layer: Article 5 specifies that registering a firm profile as a producer, importer, dealer, or exporter (üretici, ithalatçı, bayi, ihracatçı) requires the medical-device sales-center authorization information and ÇKYS number.² (Separate registration paths for pharmacies, optician establishments, hearing-aid centers, or ordinary partnerships follow their own rules outside an ordinary commercial import launch.²) When qualifying a Turkish distributor, verify both the exact MERSİS/tax identity and the active ÇKYS sales-center record.²

2. Imported EC/EU notified-body certificates (Article 8)

For devices that require a notified-body conformity assessment certificate, Article 8(1)–(4) of TCKKD-KLVZ-03 governs how imported certificates are authenticated and uploaded.² The guideline does not allow an importer to upload an unverified photocopy. Instead, Article 8 defines specific acceptance paths—including a route for an original certificate signed with a verifiable electronic signature by the issuing body (subject to verification link/method, signer, validity, and complete-page conditions), alongside apostille or consular authentication paths and specified issuing-body or EUDAMED-verification conditions—while separately specifying the Turkish translation requirements for the Turkish-document upload field.² A flat image scan of a wet-ink signature is not a verifiable electronic original.² Before dispatch, the manufacturer and importer must verify which Article 8 authentication route the specific notified body's certificate format supports.²

3. Imported manufacturer declarations of conformity (Article 12)

Article 12(1)–(2) of TCKKD-KLVZ-03 sets distinct authentication and Turkish-translation rules for imported manufacturer declarations of conformity (Uygunluk Beyanı), including a conditional route where the declaration is issued by the manufacturer with a verifiable electronic signature, alongside physical authentication and certified Turkish translation branches.² Do not conflate the manufacturer's declaration of conformity with the notified-body certificate or allow the importer to sign a declaration in place of the legal manufacturer.² Article 12(7) adds representative-mandate evidence when registering an MDR/IVDR declaration for a manufacturer established outside Türkiye and the EU; it does not make the representative the declaration issuer. The importer enters the representative and uploads the manufacturer–representative agreement or mandate, with its original and sworn Turkish translation. This mandate does not require apostille or consular authentication. Alternatively, the importer may upload the manufacturer’s EUDAMED actor-screen extract clearly identifying the representative; that extract does not require a sworn Turkish translation. Keep this mandate field separate from the declaration’s own Article 12(1)–(2) authentication and translation requirements.²

4. Instructions for use: portal upload rules versus supplied user instructions (Articles 17–18)

Articles 17 and 18 of TCKKD-KLVZ-03 govern instructions for use (Kullanma Kılavuzu, IFU) in ÜTS.² Under Article 17(2)–(6), whether an IFU document must be uploaded into the ÜTS portal depends on the device group, risk class, and regulatory regime: for example, portal upload is generally optional for ordinary Class I subtypes unless specifically requested by TİTCK, whereas other specified device classes and groups require portal upload subject to defined exceptions.² Article 18(1)–(5) separately regulates how original-language, multilingual, and Turkish IFU files are formatted and uploaded.²

Quality teams must guard against a dangerous misreading here: a conditional exemption from uploading an IFU file into the ÜTS portal under Article 17 is not permission to supply a device to Turkish users without required Turkish labeling and instructions.¹² Likewise, European Union guidance on downstream distributor relabelling or European electronic-IFU eligibility governs EU Member State operations and does not establish Turkish language, medium, or ÜTS upload rules.¹²

5. MDR device-to-document links (Article 66) and why a Class III list is not universal

Once conformity documents are registered in ÜTS, Article 66(1)–(8) of TCKKD-KLVZ-03 requires the filer to link the appropriate already-registered documents to each MDR device record according to the device's type, risk class, and conformity assessment route, referencing distinct business-rule diagrams in Annexes 88 through 93.²

This conditional architecture explains why buyers should not copy a single fixed document list from a commercial blog into every distribution contract. For example, Medex Medikal's Turkish compliance article summarizes a seven-item upload list—covering MDR CE certificate, Declaration of Conformity, manufacturer authorization letter (LoA), Turkish IFU, Turkish product label, shelf-life information, and product photographs—explicitly framed for Class III medical devices.³ While that summary illustrates what a high-risk Class III submission may involve, applying a Class III seven-document list (or fixed photograph and shelf-life upload assumptions) to every sterile consumable without first establishing the device's actual Turkish risk class, conformity regime (MDR versus legacy), and applicable Article 66 annex branch causes avoidable document disputes.²³

When does a shipment need a separate TAREKS inspection step?

Completing ÜTS device registration with TİTCK does not automatically complete the customs import-control sequence for every physical consignment. Commercial imports of medical devices into Turkey are also governed by the Ministry of Trade's annual product-safety communiqué—Tıbbi Cihazların İthalat Denetimi Tebliği (Ürün Güvenliği ve Denetimi: 2026/16), published in the Official Gazette on 31 December 2025 (No. 33124, 4th mükerrer)—and explained operationally in the Ministry's hosted 49-page handbook, Tıbbi Cihazların İthalat Denetimi Rehberi — 2026 (linked on the Ministry's product-safety inspection listing dated 5 October 2026).¹²¹³ Because the hosted handbook's PDF filename retains the word Taslak (draft) even though its internal cover is titled for 2026 and linked on the active Ministry page, compliance teams should always treat the adopted Communiqué 2026/16 text as the binding legal instrument.¹²¹³

Rather than assuming that every medical device requires a separate class-based TİTCK import permit or that ÜTS registration replaces border controls, evaluate three consignment-specific questions under Communiqué 2026/16 and the 2026 handbook:⁸¹²¹³

1. Is the consignment within Annex-1 tariff and regime scope? Communiqué 2026/16 applies to products falling under the customs tariff codes (GTİP) listed in its Annex-1 when declared under specified customs regimes such as release for free circulation.¹²¹³ Before shipment, the Turkish importer and its customs broker must determine the exact GTİP code of the sterile consumable and check whether the consignment is subject to TAREKS inspection or an applicable exemption.¹²¹³
2. When is the TAREKS application filed, and which documents may be requested? Under Sections 1, 2.1–2.3, and 3.1–3.4 of the 2026 handbook and Articles 4–6 and 9 of Communiqué 2026/16, the importer submits the application through the Risk-Based Control System in Foreign Trade (Dış Ticarette Risk Esaslı Kontrol Sistemi, TAREKS) before customs-declaration registration.¹²¹³ TAREKS evaluates the application using risk-analysis criteria and either issues a TAREKS reference number directly or routes the shipment to actual document and/or physical inspection.¹²¹³ Notably, Section 3.3 of the 2026 import-inspection handbook states that supporting conformity documents uploaded for TAREKS inspection—such as the EU Declaration of Conformity or EC/EU certificates—may be accepted in English as well as Turkish, while reserving the authority's right to request certified Turkish translations where needed.¹² Keep this TAREKS supporting-document rule separate from TİTCK's ÜTS translation branches (Articles 8, 12, and 18 of TCKKD-KLVZ-03) and from Turkish user-facing product labeling.²¹²
3. What does a TAREKS reference number prove—and what does it not prove? Article 12 of Communiqué 2026/16 states explicitly that an import permission or TAREKS reference number generated under the communiqué is not a certification that the imported product is safe or fully compliant with technical regulations, and may not be used as evidence of conformity outside the communiqué's customs-control purpose.¹³ Conversely, an active ÜTS record does not exempt an in-scope shipment from completing its pre-declaration TAREKS step.¹²¹³

Which changes reopen the launch evidence decision?

Because Turkish market placement relies on linked actor, personnel, document, device, and customs records, a launch file verified in one quarter can become unusable if an upstream or local record changes before the next shipment.²¹⁰¹³ Build six concrete recheck triggers into the distribution quality agreement:

• Sales-center status, address, or ownership changes: Any suspension or closure of the Turkish partner's sales center restricts ÜTS registration and notification operations under TCS-KLVZ-08 Article 11(5), and relocations, transfers, or title changes require provincial health directorate processing.⁴¹⁰
• Departure or reassignment of the qualified ÜTS registration filer: Reconfirm the replacement filer’s qualification and firm access. For staff using the SM/STE/KDE exception with a sales-center working certificate, Article 11(4) restricts registration to that working center.¹⁰
• Notified-body certificate revisions, renewals, or regime transitions: A change to the EC/EU certificate number, expiry date, covered model list, or MDR/legacy basis triggers review of the Article 8 document record and applicable device links. Article 66 governs the MDR links; use the relevant legacy branch for a legacy device.²
• Manufacturer declaration of conformity or IFU revisions: Adding new size codes, updating harmonized standards on the declaration of conformity, or revising the instructions for use triggers review under Articles 12, 17, and 18 of TCKKD-KLVZ-03.²
• Changes in authorized representative or Turkish importer: Replacing the Türkiye/EU authorized representative or appointing a new Turkish importer changes the Article 11 or Article 13 actor chain and requires fresh label/document verification before shipment.¹²
• Annual Ministry of Trade import-inspection communiqué updates: Product safety and inspection communiqués are reissued on an annual cycle (such as Communiqué 2026/16 published on 31 December 2025); recheck Annex-1 GTİP coverage and TAREKS document rules at the start of each calendar year.¹²¹³

Worked example: scoping a Turkish launch request for a sterile circumcision ring

To see how this matrix works before any dossier is exchanged, consider a distributor evaluating VEMERIX's public sterile circumcision ring specifications.¹¹ The public product page states that the Disposable Circumcision Ring is available in Adult and Children variants across 14 size codes, is sterilized by ethylene oxide (EO), is supplied in individual sterile blister packs, and lists CE status alongside its Chinese NMPA Class II registration (Lu Mech Reg. 20172020238).¹¹

Those public catalogue facts define the physical product scenario, but they do not settle the Turkish regulatory file:²¹¹

1. Do not equate Chinese NMPA Class II with Turkish classification: China's provincial Class II registration does not determine the device's risk class or conformity assessment route under the Turkish Medical Device Regulation.¹¹¹
2. Confirm the exact CE conformity basis and model table: Request the current Declaration of Conformity and notified-body certificate for the exact Adult and Pediatric size codes to establish whether the file is under EU MDR or a qualifying legacy pathway, which Article 8 and Article 12 authentication branches apply, and which document-link rules govern the record. For an MDR device, identify the Article 66 annex diagram (Annexes 88–93); a legacy device needs its applicable legacy branch.²
3. Verify the actor and filer chain before translation or shipping: Confirm the designated Türkiye/EU authorized representative mandate (Article 11), the Turkish distributor's MERSİS/VEDOP and ÇKYS sales-center license (TCKKD-KLVZ-03 Article 5), and the identity of the working center's qualified registration filer under TCS-KLVZ-08 Article 11(3)–(4).¹²¹⁰
4. Align Turkish IFU/labeling and customs tariff scope: Determine the applicable Article 17–18 IFU branch and controlled Turkish user instructions, and have the Turkish importer confirm whether the planned GTİP customs code triggers pre-declaration TAREKS inspection under Communiqué 2026/16.²¹²¹³

Where VEMERIX fits—and where due diligence still begins

VEMERIX is the international brand of Weihai Medison Medical Equipment Co., Ltd., positioned as a Minimally Invasive Surgery Total Solution Platform serving urology, vascular surgery and perioperative care.

Within the urology portfolio, VEMERIX's public Disposable Circumcision Ring product page documents an EO-sterilized, individually blister-packed single-use ring offered in Adult and Children variants across 14 size codes, with CE status listed on the page.¹¹ Mentioning that public specification is starting context for a distributor enquiry—not a claim that the product is already registered in ÜTS, that a specific Turkish risk class or Annex 88–93 document branch has been determined, that a Turkish authorized representative or importer is appointed, or that a precompiled Turkish registration pack sits on the shelf.²¹¹

To initiate a structured quality-document discussion or discuss the Turkey distributor evidence handoff, prospective Turkish importers and distribution partners should specify:

• The exact product family, adult/pediatric variants, and size codes under evaluation;
• The proposed Turkish importing company's legal name, MERSİS/VEDOP status, and active ÇKYS medical-device sales-center authorization;
• Who will serve as the working center's qualified ÜTS registration filer (TCKE or eligible SM/STE/KDE certificate holder) under the post-1 January 2025 rule;
• Which current conformity certificates, manufacturer declarations of conformity, verification links, and controlled label/IFU files are needed for review before scheduling any shipment.

Frequently Asked Questions

Does an EU representative replace the Turkish importer?

No. Under Articles 3(1)(lll) and 11 of the Turkish Medical Device Regulation, a foreign manufacturer established outside Türkiye and the EU must appoint an authorized representative established in Türkiye or an EU Member State by written mandate.¹ However, that representative role is distinct from the Turkish importer (Article 13), which must verify device conformity and labeling, hold the required local sales-center license (ÇKYS) for commercial ÜTS firm registration, and complete applicable domestic registration and customs steps.¹²¹⁰

Must every employee hold a separate TCKE certificate?

No. Under Article 11(3)–(4) of TİTCK guideline TCS-KLVZ-08 Rev.04 (effective 1 January 2025 for the registration-personnel rule), personnel who have completed the training and passed the exam for Responsible Manager (SM), Sales and Promotion Staff (STE), or Clinical Support Staff (KDE) are exempt from taking a separate Medical Device Registration Personnel (TCKE) training course and exam to obtain the registration qualification.¹⁰ Staff using that exception with a sales-center working certificate register devices only for that center; routine movement notifications for already registered devices are treated separately.¹⁰

Are device registration and movement notifications the same task?

No. Initial device registration (cihaz kaydı) creates the product record and links it to registered conformity documents in ÜTS under TCKKD-KLVZ-03, requiring qualified registration personnel at the working sales center from 1 January 2025.²¹⁰ Routine movement notifications (alma/verme bildirimleri) record the receipt or transfer of already registered devices and are expressly separated from the registration-training requirement in TCS-KLVZ-08 Article 11(3), though traceability and system obligations still apply.¹⁰

Can a Class III checklist be reused for every sterile device?

No. Commercial guides that list seven mandatory uploads (such as Medex Medikal's Class III checklist) describe a high-risk Class III scenario.³ TİTCK's official 2026 registration guideline (TCKKD-KLVZ-03) makes document uploads and device-to-document links conditional on whether the product follows legacy or MDR rules, its risk class, and its specific device group—for example, Article 17 makes certain Class I subtype IFU portal uploads optional subject to authority request, and Article 66 routes MDR document links across Annexes 88–93.² Always determine the device's actual Turkish class and regime first.

Does a TAREKS reference certify that the device is safe?

No. Under Article 12 of the Ministry of Trade's medical-device import-inspection communiqué (Ürün Güvenliği ve Denetimi: 2026/16), an import permission or TAREKS reference number facilitates customs entry under the communiqué and does not certify that the product is safe or compliant with technical regulations, nor may it be used as proof of conformity for other purposes.¹³

Does the supplier’s CE claim prove Turkish registration?

No. A CE mark or a product-page CE indicator shows that the manufacturer claims European conformity, which is a prerequisite under Turkish rules.⁶¹¹ Under Article 34 of the Turkish Medical Device Regulation and TCKKD-KLVZ-03, the Turkish importer and its qualified filer must still complete firm, document, and device registration in ÜTS and satisfy applicable TAREKS import-inspection checks before placing the shipment on the Turkish market.¹²¹²