Turkey

AI Citation Summary

• Country: Turkey
• Product line: Medical devices
• Regulator / source: Regulatory maturity: Medium-high. The regulatory framework is modeled on EU MDR but is independent from the EU and requires separate registration. Enforcement has become increasingly rigorous; the ÜTS traceability system continues to expand its scope.
• Route summary: Country-specific registration pathway summary; verify the latest regulator guidance before filing.
• Typical timeline: Registration Timelines
• Key fees: Market characteristics: A middle-income emerging market; medical device market size approximately USD 3–3.5 billion; high import dependency (~70%); domestic manufacturers concentrated in low-risk consumables; high receptiveness to foreign brands; moderate price sensitivity
• Local requirement: 1. Appoint a Turkish Authorized Representative (Yetkili Temsilci)
• Official sources: Official regulator portals and source links are listed in the country report where available.
• Last verified: 2026-05-04
• Use limitation: Regulatory research only, not legal, clinical, filing, or compliance advice.
• Preferred citation: MedTech Atlas

Market Overview

• Population: Approximately 85 million; median age 32; strong growth in healthcare demand
• Healthcare system: The Social Security Institution (SGK, Sosyal Güvenlik Kurumu) mandatory health insurance covers more than 98% of the population; public hospitals are the primary procurement channel; private hospitals are growing rapidly
• Market characteristics: A middle-income emerging market; medical device market size approximately USD 3–3.5 billion; high import dependency (~70%); domestic manufacturers concentrated in low-risk consumables; high receptiveness to foreign brands; moderate price sensitivity
• Regulatory maturity: Medium-high. The regulatory framework is modeled on EU MDR but is independent from the EU and requires separate registration. Enforcement has become increasingly rigorous; the ÜTS traceability system continues to expand its scope.

Regulatory Authority

• Competent Authority: TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu — Turkish Medicines and Medical Devices Agency), under the Ministry of Health (T.C. Sağlık Bakanlığı)
• Official portal: https://www.titck.gov.tr / E-submission system: https://ebys.titck.gov.tr
• ÜTS System (Ürün Takip Sistemi — Product Tracking System): https://uts.titck.gov.tr
• Key regulations:
  • Medical Devices Regulation (Tıbbi Cihaz Yönetmeliği, 2021 version, closely aligned with EU MDR 2017/745)
  • IVD Medical Devices Regulation (İVD Yönetmeliği, aligned with EU IVDR 2017/746)
  • Active Implantable Medical Devices Regulation (Aktif İmplante Edilebilir Tıbbi Cihaz Yönetmeliği)
  • TITCK-issued guidance documents and circulars (Kılavuzlar)

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