Medical Device Regulation in Türkiye
Türkiye regulates medical devices through the Turkish Medicines and Medical Devices Agency (TİTCK) under the Ministry of Health. The regulatory framework is closely aligned with the EU Medical Device Regulation, reflecting Türkiye's EU accession harmonization process. Türkiye is one of the largest medical device markets in the region, with a well-established national registration system (ÜTS).
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Sources Tracked by Qalico
Qalico continuously monitors 1 references across guidelines, regulations, and standards for Türkiye.
Guidelines
Device Classification
Türkiye follows a classification system harmonized with the EU MDR Annex VIII rules. Class I devices are low risk (e.g., tongue depressors, reusable surgical instruments). Class IIa devices are low-medium risk (e.g., hearing aids, dental crowns). Class IIb devices are medium-high risk (e.g., ventilators, X-ray machines). Class III devices are the highest risk (e.g., cardiovascular stents, total joint prostheses).
Official classification guidance →Official Guidance Documents
Official portal for medical device regulation, guidance, and circulars from the Turkish Medicines and Medical Devices Agency.
The national Product Tracking System (ÜTS) for registration and traceability of medical devices in Türkiye.
Official publication source for Turkish medical device regulations and amendments.
Standards & Key Principles
Applicable Standards
Key Principles
- CE marking is required for medical devices placed on the Turkish market, reflecting EU harmonization.
- All devices, manufacturers, and economic operators must be registered in the ÜTS (Product Tracking System).
- An in-country Turkey Authorized Representative is required for foreign manufacturers.
- Turkish language labeling and instructions for use are mandatory.
- EU Notified Body certificates are recognized, but devices must also be registered in ÜTS.
- Clinical investigations conducted in Türkiye require TİTCK authorization and ethics committee approval.
Pre-Market Requirements
All medical devices must be registered in the Product Tracking System (ÜTS) before being placed on the Turkish market. This includes registration of the manufacturer, authorized representative, and the individual device.
CE marking is required for all medical devices. The conformity assessment follows procedures aligned with the EU MDR, involving Notified Bodies for Class IIa, IIb, and III devices.
Foreign manufacturers must appoint a Turkey Authorized Representative responsible for ÜTS registration and regulatory liaison with TİTCK.
Manufacturers must maintain comprehensive technical documentation aligned with EU MDR requirements, available for review by TİTCK.
Post-Market Requirements
Serious incidents, near-incidents, and field safety corrective actions must be reported to TİTCK through the designated reporting system.
Manufacturers must maintain PMS systems and submit periodic reports as required by TİTCK, aligned with EU MDR post-market surveillance requirements.
TİTCK conducts market surveillance activities including inspections, product sampling, and compliance assessments for devices on the Turkish market.
Field safety corrective actions including product recalls must be coordinated with TİTCK, with notifications recorded in the ÜTS system.
International Recognition & Reliance
Türkiye's medical device regulations are harmonized with the EU MDR as part of the EU Customs Union and accession process. CE-marked devices are recognized subject to ÜTS registration.