Turkey

The primary regulatory authority for health products in Turkey is the Turkish Medicines and Medical Devices Agency (TİTCK), operating under the Ministry of Health. The main governing legislation includes the Pharmaceutical and Medical Preparation Law (Law No. 1262), the Medical Devices Regulation aligned with EU MDR 2017/745 and IVDR 2017/746 frameworks, and various ministerial circulars and communiqués governing pharmaceuticals, diagnostics, and digital health solutions. The general approval process involves submission of a dossier to TİTCK, technical and scientific evaluation, possible requests for additional data, and issuance of a marketing authorization or conformity certificate depending on product category. Digital health products are increasingly reviewed under an evolving software-as-a-medical-device (SaMD) framework, reflecting Turkey's efforts to modernize its regulatory architecture.

All applicants must appoint a local authorized representative or license holder (ruhsat sahibi) established in Turkey, which is a mandatory prerequisite for marketing authorization. Turkey accepts dossiers prepared according to the Common Technical Document (CTD) format for pharmaceuticals, and conformity documentation aligned with EU standards for medical devices and in vitro diagnostics. Turkey has implemented a reference pricing and parallel import framework for pharmaceuticals, and the country has progressively harmonized its medical device regulations with EU MDR and IVDR, including requirements for Unique Device Identification (UDI) registration in the national TITUBB/ÜTS (Device Tracking System) database. Recent reforms have focused on accelerated pathways for innovative products, mandatory post-market surveillance, and strengthened pharmacovigilance and vigilance reporting obligations.

Public procurement of health products in Turkey is centrally coordinated through the Ministry of Health, primarily via the Health Supplies Management Department (Sağlık Malzemeleri Yönetimi). The Central Physician Appointment System and hospital-level procurement are supplemented by national framework agreements and tenders managed through the Public Procurement Authority (Kamu İhale Kurumu, KİK) under Law No. 4734 on Public Procurement. Pharmaceuticals reimbursed under the Social Security Institution (Sosyal Güvenlik Kurumu, SGK) system are subject to reference pricing, price negotiation, and inclusion in the reimbursement positive list (SUT), which is a critical gateway for market access in the public channel. Medical devices and diagnostics procured by public hospitals must be registered in the ÜTS tracking system prior to tender participation, and price listing with the Ministry of Health is required for reimbursable items.

The private sector represents a significant and growing channel in Turkey, encompassing private hospitals, pharmacy chains, and diagnostic laboratory networks, all operating under SGK reimbursement contracts or out-of-pocket payment models. Turkey is an upper-middle-income country and is not a primary recipient of major donor-funded procurement programs such as those administered by UNICEF Supply Division, the Global Fund, Gavi, or USAID; however, select public health initiatives may involve international agency collaboration. Turkey maintains explicit local manufacturing preference policies, offering pricing advantages of up to 15 percent for domestically manufactured pharmaceuticals and incentivizing local production of medical devices and active pharmaceutical ingredients (APIs) through investment support schemes coordinated by the Ministry of Industry and Technology. These policies are part of Turkey's broader Health Transformation Program and strategic goals to reduce import dependency in the health sector.