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Turkey

Market Overview Population: Approximately 85 million; median age 32; strong growth in healthcare demand Healthcare system: The Social Security Institution (SGK, Sosyal Güvenlik Kur...

Updated: 2026-05-04

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Reference approval strategy

FDA / CE / MDSAP / NMPA benefits for this market

These factors can reduce evidence-building work, support review confidence, or shape the filing strategy. They do not automatically replace local registration.

US FDA

510(k) / De Novo / PMAModerate benefit

FDA evidence is useful technical and clinical support, but the local authority still performs an independent review.

Likely benefit
  • Use FDA review summaries, clearance or approval letters, test reports, clinical evidence, and software or electrical-safety files as support.
  • May reduce technical questions when the intended use, model scope, and evidence package match the local filing.
Limit
  • Does not remove local holder, language, labeling, fee, import, or post-market obligations.
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EU CE

MDR / IVDRStrong benefit

CE documentation is highly reusable and may support reference, reliance, or overseas conformity assessment routes.

Likely benefit
  • Reuse MDR/IVDR technical documentation, clinical evaluation, ISO testing, GSPR or essential-principles mapping, labeling, and PMS evidence.
  • Often helps build CSDT, IMDRF, or local-format technical files faster.
Limit
  • Does not replace local registration or local representative responsibilities outside the CE-recognized route.
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MDSAP

Single QMS auditIndirect QMS signal

MDSAP mainly supports ISO 13485/QMS maturity and does not reduce product review directly.

Likely benefit
  • Reduce duplicate quality-system audits and support ISO 13485, CAPA, complaints, supplier controls, design controls, and production controls.
  • Most useful when the market accepts MDSAP directly or when the application depends on QMS maturity.
Limit
  • Does not authorize product sale and does not replace safety, performance, or clinical evidence.
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China NMPA

China registration / filingSupportive evidence

NMPA approval can serve as prior-market evidence and a commercial credibility signal, especially for China-made products.

Likely benefit
  • Use NMPA approval as prior-registration evidence, China market history, and product-maturity support.
  • Convert ISO/IEC-aligned testing, clinical, risk-management, and PMS documents from the NMPA file into the local dossier.
Limit
  • Do not assume automatic recognition; China-only GB/YY evidence may need retesting or restructuring.
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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: Varies by product class, pathway, dossier quality, and regulator questions.
  • 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: Local holder, agent, importer, or authorized representative requirements may apply.
  • 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)

Device Classification

Local Classification Risk Level EU/FDA Equivalent Notes
Sınıf I Low risk EU MDR Class I / FDA Class I General devices; most require no pre-market review, but registration is mandatory
Sınıf IIa Medium-low risk EU MDR Class IIa / FDA Class II Notified Body involvement required; TITCK recognizes select EU Notified Bodies
Sınıf IIb Medium-high risk EU MDR Class IIb / FDA Class II More rigorous technical documentation review
Sınıf III High risk EU MDR Class III / FDA Class III Implants and high-risk active devices; longest review period

Classification rules are largely identical to the EU MDR Annex VIII rules (Rules 1–22).

Registration Pathway

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