Product Registration & UMT (Product Tracking System) Procedures

UMT and TITCK product registration specialist

Seamless Entry into the Turkish Medical Market: TITCK and UMT Compliance

Legally placing medical devices and related products on the market in Türkiye requires full compliance with the regulations of the Turkish Medicines and Medical Devices Agency (TITCK) and the UMT (Product Tracking System). A small mistake in steps such as company registration, product registration or barcode matching can delay your product's market launch — or halt it entirely.

At Şah Grup, with our deep experience in UMT and TITCK processes, we manage the entire process on your behalf — from company registration to product notifications, from post-registration follow-up to update management — ensuring your products have a secure, uninterrupted presence in the Turkish market.

Our Comprehensive UMT and TITCK Consulting Services

We offer an end-to-end service model that secures your legal compliance in the Turkish market:

1. UMT Company and Product Registration Process

We manage your registration and enrollment procedures in the UMT (Product Tracking System) fully and in accordance with current legislation.

Company Registration: Complete registration of your company in UMT according to your status as manufacturer, importer or dealer.
Product, Dealer and Warehouse Registrations: Accurate and up-to-date entry of information on the products you will place on the market, along with authorized dealer and warehouse details.
UBB (National Data Bank) Barcode Matching: Error-free matching of your products' barcode and GTIN information in the National Data Bank.
Authorized Representative Procedures: Managing authorized representative appointment and notification procedures in Türkiye for overseas manufacturers.

2. TITCK Notification and Compliance Procedures

We take full ownership of your notification and compliance obligations toward the Turkish Medicines and Medical Devices Agency.

Classification Notification: Correctly determining your product's risk class and managing the corresponding notification process.
Technical File Submission: Fully compiling the technical and administrative documents requested by the Agency and preparing them for application.
Market Placement Notifications: Filing the legal notifications regarding placing the product on the market within the required timeframe and with accurate content.
Audit and Request Management: Staying prepared for any additional information requests or audit processes that may arise from TITCK.

3. Post-Registration Follow-Up and Update Management

Once registration is complete, we operate follow-up mechanisms that ensure the continuity of your compliance.

Product Updates: Timely reflection of changes in product specifications, packaging or label information in UMT.
Recall and Withdrawal Notifications: Notifying and managing product recall or withdrawal processes in accordance with legislation whenever necessary.
Periodic Compliance Checks: Regularly reviewing your registrations for compliance with current legislation.
Notification Calendar Management: Tracking your legal deadlines and notification obligations to prevent any delay.

Why Şah Grup?

Strategic Approach:

We don't treat UMT and TITCK processes as a mere obligation — we chart a roadmap that gets your product to market as quickly and smoothly as possible.

International Expertise:

Thanks to our experience working with overseas manufacturers and importers, we manage Türkiye-specific registration requirements in harmony with your global processes.

Single-Point Solution:

We run the entire process through a single team, from company registration to post-registration updates, preventing any loss of time or resources.

Up-to-Date Expertise:

By closely tracking changes in UMT and TITCK legislation, we ensure your registrations always remain current and compliant.

Take the first step to establish your products securely in the Turkish market today. Get in touch with us to meet our expert team and build a roadmap for your UMT/TITCK processes.