OUR SERVICES

Our mission is to provide reliable, end-to-end regulatory solutions that enable medical device and IVDR manufacturers to enter and grow in the Turkish market with confidence — ensuring compliance, operational efficiency, and long-term regulatory sustainability.

MDR & IVDR COMPLIANCE IN TURKEY

Ardis Consulting delivers comprehensive medical device registration services in Türkiye, supporting manufacturers through every operational and regulatory step required for market authorization. Our scope includes documentation review, apostille coordination, certified Turkish translations, ÜTS data entry, barcode structuring, and submission management with the Turkish Medicines and Medical Devices Agency — ensuring efficient approval, regulatory accuracy, and sustained compliance.

Ardis Consulting works responsibly for fast and accurate application processes. Monitoring the authority review process, providing ongoing follow-up and status management until approval is secured.

REGULATORY LIFECYCLE & COMPLIANCE CONSULTING

We provide end-to-end regulatory lifecycle consultancy to ensure medical and in-vitro (IVD) medical device manufacturers maintain continuous compliance in Türkiye. From submission dossier preparation, certified regulatory translations to post-market surveillance and vigilance reporting. Our services ensure accuracy, authority alignment, and sustained market conformity. MDR IVDR

MARKET ACCESS & STRATEGIC ENTRY CONSULTING

We support manufacturers with data-driven market intelligence and regulatory pathway strategy to enable informed entry into the Turkish medical device market. Our consulting integrates reimbursement dynamics, competitive positioning, distributor mapping, and regulatory planning to build sustainable and commercially viable market access models.

MEDICAL DEVICE REGISTRATION IN TÜRKİYE

Under MDR Registration Services in Türkiye, Ardis Consulting manages the full documentation and submission lifecycle on behalf of the manufacturer. The open communication and monitoring periodically the authority review process, providing ongoing follow-up and status management until approval is secured and for renew processes.

TÜRKİYE REGISTRATION HOLDER TRH

Ardis Consulting provides in-country regulatory representation for medical device and IVDR manufacturers, acting as the Registration Holder and official liaison with the Turkish Medicines and Medical Devices Agency. We manage product registrations, authority communications, vigilance reporting, and Field Safety Corrective Actions (FSCA) to ensure continuous regulatory compliance in Türkiye.

REIMBURSEMENT & MARKET ACCESS

Ardis Consulting supports medical device manufacturers in navigating Türkiye’s reimbursement and market access landscape through end-to-end coordination of Social Security Authority applications, national code alignment, and pricing dossiers. We also guide manufacturers through centralized public procurement pathways to enable structured and sustainable commercial market entry. DMO SGK ÜTS