Do I need CE marking to sell medical devices in Turkey?

Yes. CE marking under EU MDR (or the previous MDD for devices under active transition) is the primary basis for market authorisation in Turkey. However, CE marking alone is not sufficient — you must also register the product in Turkey’s UBB (Ürün Bilgi Bankası, Product Information Bank), appoint a local authorised representative (yetkili temsilci), and comply with TITCK registration requirements. The registration process typically takes 2–6 months depending on device class and completeness of documentation.

What is EKAP and how do I use it for Turkish hospital tenders?

EKAP (Elektronik Kamu Alımları Platformu — Electronic Public Procurement Platform) is Turkey’s official platform for all public procurement, operated by the Public Procurement Authority (Kamu İhale Kurumu, KİK). All public hospital tenders are published on EKAP. Foreign suppliers can register on EKAP, monitor tender announcements by product category (CPV code), and submit bids either directly or through a local authorised representative or agent. Framework contracts (çerçeve sözleşme) are increasingly common for hospital consumables and diagnostic equipment.

How does SGK reimbursement affect medical device procurement in Turkey?

SGK (Sosyal Güvenlik Kurumu — Social Security Institution) provides health insurance coverage for approximately 85% of Turkey’s population and is the dominant payer for hospital medical device procurement. Devices used in SGK-covered procedures must be listed in the SUT (Sağlık Uygulama Tebliği — Health Implementation Communiqué), which sets reimbursement prices and conditions. SGK listing is a prerequisite for device reimbursement and significantly influences hospital procurement committee decisions.

What languages are required for Turkish hospital tender submissions?

Turkish (Türkçe) is mandatory for all public tender submissions in Turkey. Technical documentation, product labelling, Instructions for Use, and any clinical evidence submitted must be either in Turkish or accompanied by a certified Turkish translation. TITCK requires Turkish-language IFU and labelling for all market-placed devices. Working with an experienced Turkish distributor or regulatory affairs partner is strongly recommended for tender document preparation.

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Medical Device Procurement in Turkey: A Supplier's Guide [2026]

2026年6月15日

Turkey is one of the most significant and fastest-growing medical device markets in the Middle East and Eastern Europe region, with a healthcare sector that combines a large population base, ambitious public health investment programmes, and a regulatory framework increasingly aligned with EU standards. The Turkish medical device market is valued at approximately USD 3–4 billion annually, spanning a network of over 1,500 public hospitals, more than 550 private hospitals, and a growing diagnostics and digital health infrastructure. For foreign medical device suppliers, Turkey represents a market with substantial procurement volume, strong government healthcare spending, and a clear regulatory pathway for CE-certified products.

This guide covers the regulatory authority, registration process, reimbursement system, procurement platforms, and practical strategies for winning Turkish public hospital tenders in 2026.

Regulatory authority and registration pathway

Turkey’s medical device market is regulated by TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency), the national competent authority responsible for market authorisation, post-market surveillance, and enforcement of Turkey’s medical device regulations. TITCK’s regulatory framework is closely aligned with EU medical device legislation, making CE-certified products the practical basis for Turkish market entry.

CE marking recognition: CE marking under EU MDR (or under MDD for devices covered by EU transition arrangements) is the foundation of Turkish market authorisation. TITCK accepts CE marking as evidence of conformity for most device categories. This makes Turkey significantly more accessible than markets requiring entirely separate national testing and approval processes.
UBB registration: Beyond CE marking, all medical devices placed on the Turkish market must be registered in the UBB (Ürün Bilgi Bankası — Product Information Bank), Turkey’s national medical device registry. UBB registration is completed through TITCK’s online system and requires submission of CE certificates, technical documentation, Notified Body information, and local representative details. Registration typically takes 2–6 months depending on device class. Devices that are not UBB-registered cannot legally be placed on the Turkish market or included in public hospital tenders.
Local authorised representative (yetkili temsilci): Non-Turkish manufacturers must appoint a local authorised representative registered with TITCK. The yetkili temsilci acts as the legal point of contact for TITCK on vigilance, post-market surveillance, and registration matters. Most foreign suppliers establish Turkish market presence either through a distributor who also holds the yetkili temsilci role or by appointing a dedicated regulatory affairs representative.
Turkish-language labelling and IFU: All devices sold in Turkey must carry Turkish-language labelling and Instructions for Use. TITCK verifies language compliance during UBB registration and has market surveillance enforcement authority.
Post-market surveillance and vigilance: Serious incidents and Field Safety Corrective Actions must be reported to TITCK within the timelines specified in Turkey’s medical device regulation. TITCK coordinates closely with EU competent authorities, particularly given Turkey’s EU Customs Union membership.

If you hold a valid EU MDR CE mark, the regulatory foundation for Turkey is substantially in place. UBB registration and local representative appointment are the primary additional steps required.

SGK reimbursement and the SUT framework

SGK (Sosyal Güvenlik Kurumu — Social Security Institution) is Turkey’s dominant healthcare payer, covering approximately 85% of the population through compulsory social health insurance. Understanding SGK is essential for any supplier targeting public hospital procurement, because SGK reimbursement status directly determines a device’s commercial viability in the public sector.

SGK manages medical device reimbursement through the SUT (Sağlık Uygulama Tebliği — Health Implementation Communiqué), a comprehensive document specifying the conditions, prices, and procedures for SGK coverage. Key SUT considerations:

SUT listing requirement: Devices used in SGK-covered hospital procedures must be listed in the relevant SUT annexes. For implants, diagnostics, and devices consumed during procedures, SUT listing is effectively a prerequisite for public hospital procurement. Unlisted devices must be funded from hospitals’ own budgets — which limits adoption in a cost-constrained public sector environment.
SUT pricing dynamics: SUT sets reimbursement prices for listed devices, which act as price ceilings for hospital procurement and anchor tender pricing negotiations. Foreign suppliers should understand SUT pricing for their device categories before entering the market.
SUT listing process: New listings involve clinical evidence review by the Ministry of Health’s HTA assessment structures and pricing negotiation. The timeline from application to listing typically ranges from 12–24 months for new device categories. Strategic planning well in advance of planned market launch is essential.
Private hospital procurement: Turkey’s growing private hospital sector (550+ hospitals, growing at 8% annually) is not bound by SUT pricing and procures under commercial terms. Private hospital chains such as Acıbadem, Memorial, and Medicana can move faster on procurement decisions and provide valuable early clinical reference evidence ahead of public hospital roll-out.

EKAP and public procurement platforms

All Turkish public hospital procurement is governed by Law No. 4734 (Kamu İhale Kanunu — Public Procurement Law) and administered through the KİK (Kamu İhale Kurumu — Public Procurement Authority). The primary procurement channels are:

EKAP (Elektronik Kamu Alımları Platformu): Turkey’s official e-procurement platform where all public contracts above specified thresholds are published and managed. EKAP provides tender notices, tender documents, award notices, and framework agreement announcements. Filtering by CPV code categories (medical device codes: 33100000 and sub-categories) is the most efficient way to monitor relevant opportunities.
Central Health Purchasing (Merkezi Sağlık Satın Alma Birimi): Turkey’s Ministry of Health operates a central purchasing unit that negotiates large-scale framework contracts for high-volume hospital consumables, diagnostics, and capital equipment on behalf of all Ministry of Health-affiliated hospitals. Winning a central framework agreement provides access to the entire public hospital network through a single commercial process.
Individual hospital tenders: Public hospitals also run their own procurement processes for non-centrally purchased items, specialty equipment, and locally required configurations. These appear on EKAP as individual hospital tenders and require separate bid submissions.
Kamu Hastaneleri Genel Müdürlüğü (KGHM): The General Directorate of Public Hospitals coordinates procurement across Turkey’s network of Ministry of Health hospitals (over 900 hospitals). KGHM-coordinated group tenders represent significant procurement volume for hospital equipment, surgical instruments, and medical consumables.

MedStrato’s tender monitoring tracks EKAP publications and central purchasing announcements, consolidating Turkish hospital procurement opportunities into a single feed for medical device suppliers managing multi-market bid pipelines.

Compliance requirements for Turkish hospital tenders

Language: All tender submissions must be in Turkish. Technical datasheets and IFU may be submitted in English with certified Turkish translations in some contexts, but the primary submission language is Turkish. Working with an experienced Turkish distributor or regulatory affairs partner is strongly recommended.
UBB registration: Devices must be UBB-registered before they can be included in public hospital tender bids. KİK and hospital procurement committees verify UBB status as a qualification criterion. Ensure UBB registration is in place for all device variants before tendering.
CE marking documentation: Valid CE certificates must be submitted with tender bids. Given Turkey’s close alignment with EU MDR, the EU MDR compliance documentation requirements substantially overlap with Turkish tender requirements.
SGK/SUT status confirmation: For devices in categories covered by SUT, tender documents may require proof of SUT listing. Hospital procurement committees use SUT coverage as a qualification or scoring criterion, particularly for implants and high-cost devices.
ISO 13485 certification: QMS certification from an IAF-recognised accredited body is standard for medical device procurement across Turkey’s public hospital system.
Local content incentives: Turkey has local content preference policies (yerli malı belgesi — domestic goods certificate) that provide price preference to Turkish-manufactured products in public procurement. Understanding whether competitors hold yerli malı certification is important for competitive pricing strategy.

Market opportunity and key segments

Turkey’s medical device market is estimated at USD 3–4 billion annually, with public procurement accounting for approximately 60–65% of total volume. The market is growing at 8–12% annually, driven by healthcare infrastructure investment, demographic expansion, and rising chronic disease prevalence. Key opportunity segments:

Surgical and orthopaedic implants: Turkey’s growing base of certified surgical centres and the SUT reimbursement framework for implants create significant procurement volume. Cardiovascular, orthopaedic joint replacement, and spinal systems are large and growing categories.
Diagnostic imaging and laboratory systems: Public hospital infrastructure investment has driven significant capital equipment procurement for CT, MRI, ultrasound, and laboratory analysers. The Ministry of Health’s hospital modernisation programme includes regular capital equipment refresh cycles.
Consumables and single-use devices: Turkey’s high-volume public hospital system is a major buyer of surgical consumables, infusion systems, wound care products, and single-use diagnostic devices. Central framework agreements make this a highly efficient entry pathway for volume-focused suppliers.
Digital health and medical software: Turkey’s eHealth and hospital information system agenda is generating procurement for connected medical devices, point-of-care diagnostics, and clinical decision support tools, with Ministry of Health digital transformation programmes creating tender opportunities for innovative device categories.

Strategies for winning Turkish hospital tenders

Appoint the right local representative early: Your yetkili temsilci is your regulatory anchor in Turkey and typically your commercial gateway too. Choose a representative or distributor with strong TITCK relationships, existing EKAP registration, and SUT listing experience in your device category.
Prioritise SUT listing for implants and specialty devices: If your device category has SUT reimbursement implications, initiate the listing process as early as possible. Some suppliers use private hospital adoption to build clinical evidence for SUT listing applications while building market presence.
Monitor EKAP systematically: Turkish hospital tenders move quickly, with relatively short notice periods compared to EU markets. Systematic EKAP monitoring by CPV code is essential. MedStrato automates EKAP monitoring and provides advance notice of framework agreement renewals.
Prepare for central framework competition: Ministry of Health central purchasing tenders attract intense competition from both international suppliers and domestic manufacturers. Competitive pricing — anchored to SUT reference prices — combined with strong technical documentation and reliable local supply chain capabilities are the keys to framework contract success.
Build academic hospital reference sites: Turkey’s leading academic hospitals — Hacettepe, Istanbul University, Ankara University, Ege University — are clinical opinion leaders whose adoption decisions influence procurement across the public hospital system.

Common rejection reasons in Turkish hospital tenders

The most frequent technical rejection reasons for medical device suppliers in Turkish public procurement include:

Missing or expired UBB registration at the time of tender submission
CE certificate scope that does not cover the specific device models or configurations being tendered
Tender submission in English without certified Turkish translation
Missing SUT listing confirmation for device categories where SGK reimbursement status is a qualification criterion
ISO 13485 certificate from an unaccredited body or expiring within the contract period
Insufficient local content documentation in tenders with yerli malı preference criteria

Automated compliance verification prevents most documentation-related rejections. MedStrato verifies UBB registration status, CE certificate validity and scope, and regulatory documentation completeness before bid submission, flagging gaps in real time. Book a demo to see how MedStrato handles Turkish tender compliance monitoring, or explore the full feature set for multi-market medical device tender management.