Medical Product Consultancy & ÜTS / UBB Registration Services
QIS has been successfully offering medical product consultancy, ÜTS (Product Tracking System) registration, and UBB registration services to valued clients for many years, supported by a highly experienced and professional team.
What is ÜTS (Product Tracking System) Registration?
The Product Tracking System (ÜTS) is a national platform developed jointly by TÜBİTAK BİLGEM YTE and the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health. Launched in early 2014 and fully implemented by 2017, the ÜTS project aims to track and monitor medical devices and cosmetic products from production to end-user in a transparent and reliable manner.
This system allows for end-to-end traceability of all medical devices and related products. For importers, every step—from customs clearance to delivery to the end user—is tracked. Likewise, domestic manufacturers are required to register and track their products through every phase, ensuring full visibility and safety. ÜTS also facilitates the recording of statistical data for exported products.
If your company requires medical product consultancy for production, import, or ÜTS registration, QIS offers tailored support throughout the entire process.
Why is ÜTS Important?
Through ÜTS, all production, importation, and distribution processes are systematically controlled. This ensures that defective, counterfeit, or expired products are prevented from circulating in the market, thereby protecting both businesses and public health.
Further benefits of ÜTS include:
- Monitoring of testing, control, transport, and storage processes
- Inclusion in a safe product list
- Management of inventory, maintenance, calibration, and warranty tracking for medical devices
ÜTS ensures that only safe, validated, and traceable products reach the consumer.
UBB (TITUBB) Company and Product Registration
According to Article 16 of the Medical Devices Regulation (Official Gazette 03.03.2002) and Article 13 of the In Vitro Diagnostic Medical Devices Regulation (updated 09.01.2007, Official Gazette No. 26398), manufacturers and importers of medical devices and services in Türkiye are required to register with the National Data Bank of Pharmaceuticals and Medical Devices (TITUBB).
Our expert consultants at QIS are here to guide you through each registration phase, assist with documentation, and ensure compliance with current regulatory standards.
Medical Product Consultancy Services by QIS
We offer a full suite of consultancy services in the field of medical products, including:
- Medical label preparation
- UBB registration and follow-up
- Sterilization and validation services
- Medical vigilance consultancy
- Medical device distribution consultancy
- Risk analysis for medical products
- Medical device design and development
- Consultancy on device use and medical personnel interaction
- Software validation for medical technologies
- Product design services for medical devices
- ACS services and biocompatibility evaluations
- Hygiene and process validation
- ÜTS registration services
For detailed information, pricing, or questions specific to your product or company, feel free to contact QIS via the phone numbers on our website. Our knowledgeable team is ready to assist you with all your medical device registration and compliance needs.