Medical Product Certification and Health Standards in Türkiye (2025)
Türkiye’s medical product market in 2025 is shaped by updated certification procedures, digital tracking systems, and evolving health regulations. These standards apply to all stakeholders—manufacturers, importers, distributors, and clinical personnel—and must be closely followed by entrepreneurs seeking to enter the Turkish healthcare market.
Certification Processes and Training Requirements
Professionals working with medical devices in Türkiye are required to complete specific online training programs provided through the Medical Device Education System (TCESIS). Certification is granted by the Turkish Medicines and Medical Devices Agency (TİTCK) after successful completion of both training and exams. The training requirements vary depending on professional roles:
- Responsible Managers: must complete training in legislation, medical ethics, sterilized service areas, and radiation safety.
- Sales and Promotion Staff: required to take training in legislation and medical ethics.
- Clinical Support Staff: must attend training on sterilized service environments and radiation safety protocols.
All trainings are provided online, and participants must watch a minimum of 90% of the video content to be eligible for the final exams and certification process.
Health Standards and the Ürün Takip Sistemi (ÜTS)
The Product Tracking System (ÜTS) is Türkiye’s centralized platform for monitoring medical devices from production to end-use. Registration with ÜTS is mandatory for compliance in 2025. Important details include:
- Registration Requirements: all manufacturers, importers, distributors, and wholesalers must be registered with ÜTS.
- Step-by-step process:
- Company authorization via e-Government portal,
- Entry of product information including technical files, barcode, and UBB (National Data Bank) codes,
- Approval by TİTCK.
- New 2025 Restriction: as of January 1, 2025, only individuals holding a medical device certification are permitted to register products on ÜTS.
Strict compliance with ÜTS is essential to legally operate in the Turkish healthcare sector and avoid regulatory penalties.
SGK Contracts and Required Documentation
To supply medical materials through Türkiye’s Social Security Institution (SGK), companies must enter into formal contracts. The following documents are mandatory for 2025:
- Scanned copy of a valid business license,
- Document stating “No Objection to Contracting,”
- Contract form approved by the relevant Regional Chamber of Pharmacists.
Contract signing is scheduled between April 29 and May 7, 2025. Missing this window can delay businesses’ access to public healthcare tenders.
Recent Regulatory Updates
Emerging entrepreneurs should be aware of recent legal changes that carry strategic implications:
- Joint Liability Enforcement: both importers and registrants of medical devices on the ÜTS platform are now jointly responsible for warranty and technical support compliance.
- Training Exemption: authorized firms are no longer required to receive formal training to conduct ÜTS declarations, streamlining the process for experienced entities.
These updates demand a strategic approach to compliance, especially for companies involved in importing or distributing high-risk classes of medical devices.
Final Thoughts for International Entrepreneurs
To successfully enter and scale in Türkiye’s 2025 medical product market, international businesses must:
- Ensure all personnel hold the correct certifications via TCESIS,
- Establish a comprehensive ÜTS registration strategy,
- Prepare the documentation necessary for SGK partnerships,
- Stay updated on regulatory shifts affecting liability and training obligations.
By aligning with Türkiye’s evolving health regulations and digital systems, entrepreneurs can capitalize on one of the region’s most promising and regulated healthcare markets.