Entering the Turkish medical device market requires a structured approach to local regulatory frameworks, institutional enrollments, and supply chain readiness. We guide international medical technology companies through every stage of local compliance—from infrastructure establishment to public tender participation.
7 STEP COMPLAINCE & MARKET ACCESS PROCESS
Strategic selection of office and warehouse facilities fully aligned with Ministry of Health physical criteria, local tax registration, and coordination with financial/legal advisory teams
End-to-end recruitment coordination and management of official Ministry training/certification processes for mandatory Responsible Manager and Sales Personnel
⏱️~2 Months
Preparation and submission of official commitment letters, municipal operational permits, certified personnel contracts, and hands-on management of physical facility inspections.
Firm registration within the Ministry of Health central system (ÇKYS), ÜTS (Medical Device Tracking System) company enrollment, and detailed product-level / document-level compliance registration.
Timeline: ⏱️ ~1 Month
Strategic mapping and alignment of medical products with Social Security Institution (SGK) reimbursement codes (SUT) to enable public coverage.
Timeline: ⏱️ ~2 Months
Registration on the DMO procurement portal, product catalog approval submissions, sample testing coordination, and operational software training for local staff.
Access to direct, streamlined purchasing channels for public hospitals.
Timeline: ⏱️ ~2 Months
Integration with EKAP (Electronic Public Procurement Platform), qualified e-signature setup, and step-by-step workflow guidance for active tender participation.
Medical Device Registration Consulting | UTS & Health Market Access