Medex Corporate Consultancy

Your trusted partner in medical device regulations. From Ankara and Istanbul, serving clients across Türkiye and beyond.

Medex Corporate Consultancy is a specialised regulatory consultancy that manages, end-to-end, every certification and compliance process required before the Turkish Medicines and Medical Devices Agency (TİTCK) on behalf of medical device manufacturers, importers and distributors. From our offices in Ankara and Istanbul, we deliver fully compliant, fast and error-free solutions to companies across Türkiye and beyond.

In a regulatory landscape that grows more demanding each year — shaped by the European Union MDR 2017/745 and IVDR 2017/746 regulations, EUDAMED obligations, ÜTS (Product Tracking System) procedures, SUT reimbursement processes and TİTCK secondary legislation — we work to ensure that our clients maintain their speed of market access without compromising on legal compliance.

Who We Are

Medex Corporate Consultancy is built on a team that combines years of hands-on field experience in medical device regulation and ÜTS operations with up-to-the-day regulatory knowledge and a meticulous approach to dossier management. Since our founding, we have successfully completed company registrations, document registrations, product registrations, single-item notifications, inventory declarations, receive/dispatch notifications, SUT-barcode matching, DMO applications and declarations of conformity for hundreds of domestic and international companies.

We treat every file not as a routine compliance task but as a critical component of our client's commercial continuity. For a medical device company, a missing document in ÜTS can mean a container stuck at customs; a rejected application can mean a lost tender. With this awareness, we examine and submit every application down to the last detail demanded by the regulation.

Our Mission

To lift the burden of constantly evolving national and international regulatory compliance from the shoulders of medical device companies, freeing them to focus on what they do best — manufacturing, developing, marketing and growing.

Our Vision

To be the first name that comes to mind when medical device regulatory consultancy is mentioned in Türkiye — the reference firm shaping the sector through deep regulatory knowledge and process mastery.

Our Service Areas

We organise our work around a single overarching purpose: the lawful, safe and timely placement of our clients' medical devices on the Turkish market, and uninterrupted post-registration follow-up.

ÜTS Registration Processes

• ÜTS Company Registration Consultancy — ÜTS company registration is the first mandatory step for medical device sales. We complete the authorisation document, e-signature, ÇKYS code and TİTCK approval process on your behalf.

• ÜTS Document Registration Consultancy — Registration of CE certificates, declarations of conformity and Turkish labelling for your medical devices. Complete document registration for all classes from I to III, and IVDR A to D.

• ÜTS Product (Barcode) Registration Consultancy — Barcode-based product definitions in ÜTS, including GTIN-14, GMDN code matching, single-item tracking and pre-import registration assurance.

Certification & Conformity

• MDR & IVDR Declaration of Conformity Drafting — Preparation of audit-ready declarations of conformity that fully meet the Annex IV requirements of EU 2017/745 and 2017/746.

• EUDAMED Registration & SRN Acquisition — Actor registration, UDI submissions and European database integration, mandatory as of 28 May 2026.

• EC Certificate Extension Applications — Lifecycle management of CE certificate validity, including IVDR 2024/KK-3 transition period extension applications.

• Sworn Translation & Apostille Services — Notarised translations are no longer accepted in ÜTS document registration. We manage sworn translation and apostille processes with 90-day validity tracking.

Reimbursement & Public Tenders

• SUT Code – Barcode Matching Applications — The Health Implementation Communiqué (SUT) Code – Barcode matching is mandatory for medical devices to be evaluated for reimbursement by the Ministry of Health and Social Security Institution (SGK). We prepare and follow up your application files end-to-end.

• DMO Registration Applications — The State Supply Office (DMO) is the principal channel for public-sector medical device procurement in Türkiye. We manage your DMO catalogue registration on your behalf.

• Medical Device Sales Centre Authorisation Certificate — Management of authorisation certificate procurement before provincial directorates of the Ministry of Health.

Post-Registration Management

• ÜTS Process Management & Tracking — EC certificate renewal, IVDR transition application, product updates and TİTCK audit support. We continuously track all your post-registration ÜTS processes.

• Single-Item Notification, Movement & Inventory Management — Orderly, error-free handling of production, import, receive/dispatch and inventory notifications on ÜTS.

Why Medex Corporate Consultancy?

Full Regulatory Command

Our team monitors MDR, IVDR, the TİTCK Medical Device Regulation, the SUT Communiqué, ÜTS guidance documents and EUDAMED procedures on a daily basis. Every application is structured according to the latest version of the relevant legislation in force.

Flawless Dossiers, Fast Outcomes

Every rejected application means lost time and revenue for your business. We put your dossier through a multi-stage internal review and identify any missing or contradictory information before submission, not after.

Transparent Process Management

You always know exactly which application is at which stage, what is required next, and the estimated timeline for completion. Our clients never have to chase us for updates.

Comprehensive Single-Roof Service

From company registration to SUT matching, from declaration of conformity preparation to EUDAMED integration and DMO applications — every step is handled by a single, coordinated team. You will never juggle multiple consultants or offices.

Sector Experience

We have served a broad client portfolio, from domestic manufacturers to international importers, from small-scale medical operations to multinational healthcare companies. We know the sector's typical bottlenecks and their solutions first-hand.

Our Working Approach

Every client relationship begins with a discovery meeting. We will not issue a proposal until we have understood your product portfolio, your existing documentation infrastructure and your commercial objectives. Throughout the project, you are assigned a single dedicated project manager who is your first point of contact for all communication and follow-up. Once the application is complete, we remain with you for annual updates, new product additions, alignment with regulatory changes and audit support.

For us, every file is a direct stake in our client's reputation and continuity in the Turkish market. We take that responsibility seriously, which is why most of our clients build multi-year partnerships with us.

Get in Touch

Whether you need ÜTS registration, MDR/IVDR declaration of conformity, EUDAMED registration, SUT matching, DMO application or any other application process before TİTCK for your medical devices, we are ready to help. Our initial consultation and proposal process is completely free of charge.

📍 Ankara Headquarters: Ehlibeyt Mah. Tekstilciler Cad. No: 35/7, 06520 Çankaya / Ankara

📍 Istanbul Office: Cevizli Mah. Zuhal Cad. Ritim İstanbul B Blok No: 44, Maltepe / Istanbul

☎ Phone: +90 505 580 4622  |  +90 312 389 1354

✉ E-mail: medexkurumsal@gmail.com

Medex Corporate Consultancy — Regulatory Compliance, Market Access, Sustainable Trust.