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Turkey

9 articles

Regulatory

Turkey TİTCK ÜTS Medical Device Registry Teardown: Database Analysis

A quantitative teardown of Turkey's TİTCK ÜTS national medical device register: 5.78M records, domestic-vs-import split, risk-class distribution, and the 1-in-5 rejection rate.

Labeling & UDI

Arabic Labeling, UDI & Halal Certification for Medical Devices in MENA (2026)

MENA medical device labeling guide covering Arabic language rules, UDI requirements, halal certification, and country expectations for Saudi Arabia, UAE, Egypt, Israel, Turkey, and Qatar.

Digital Health & AI

Digital Health & AI Medical Device Regulation in MENA: SFDA, EDE & TITCK Frameworks

Guide to digital health and AI medical device regulation in MENA, covering Saudi SFDA, UAE EDE, Turkey TITCK, Israel AMAR, SaMD, mHealth, DTx, and compliance strategy.

IVD & Diagnostics

MENA IVD & Diagnostics Registration: Country-by-Country Requirements

Compare IVD registration requirements across MENA, including Saudi SFDA, UAE EDE, Egypt EDA, Turkey TITCK, Israel AMAR, companion diagnostics, performance evidence, and point-of-care rules.

Clinical Evidence

MENA Medical Device Clinical Investigation & Trials: Regulatory Requirements by Country

Compare MENA medical device clinical trial requirements, including Saudi SFDA, UAE, Egypt, Turkey, Israel, Qatar, authorization routes, evidence expectations, and multi-country trial planning.

Commercialization

MENA Medical Device Customs, Import & Free Zone Strategy: Complete Guide

Plan MENA medical device import, customs, and free zone strategy, including GCC tariffs, Saudi SABER and ZATCA, UAE EDE, Egypt EDA, Turkey TITCK, and duty optimization.

Reimbursement & Market Access

MENA Medical Device Reimbursement and Health Insurance Guide (2026)

Compare MENA medical device reimbursement systems, including Saudi CHI and NPHIES, UAE Daman, Turkey SGK, Israel Health Basket, Egypt UHIA, co-payments, and market access strategy.

Post-Market Surveillance

MENA Post-Market Surveillance & Vigilance: SFDA, EDE & Regional Requirements (2026)

Compare MENA post-market surveillance and vigilance rules for devices, including Saudi SFDA, UAE EDE, Turkey TITCK, Israel IRH, Egypt EDA, reporting timelines, PSURs, and shortage notices.

Regulatory

Turkey TITCK Medical Device Registration Guide 2026: Process, Fees & Timeline

Turkey medical device registration guide for 2026, covering TITCK rules, EU MDR/IVDR alignment, UTS registration, representative duties, fees, and timelines.