How to Place a Medical Device Manufactured in Hong Kong or China on the Turkish Market

1. Regulatory Framework and Initial Classification Türkiye represents a strategically significant medical device market with a regulatory framework that closely mirrors European Union legislation. The process begins with the correct classification of the device in accordance with EU medical device regulations (MDR/IVDR). The risk class determines the applicable conformity assessment route and the scope of mandatory documentation. Manufacturers must ensure that all regulatory documents, including the Declaration of Conformity and EC Certificate, are prepared in strict alignment with the determined class. Source: https://www.medikozceviri.com/

2. Barcode Structure and Traceability Following classification, a product barcode structure must be established. In Türkiye, barcodes serve regulatory and traceability purposes beyond mere commercial functions. The barcode data must be fully consistent with the product’s name, model, manufacturer details, and packaging configuration. Any discrepancy identified during the registration process may result in rejection or delay. Source: https://www.medikozceviri.com/

3. Mandatory Local Representation and Language Requirements Non-Turkish manufacturers cannot place devices on the market independently and must appoint a local distributor or authorized representative based in Türkiye. This entity assumes legal responsibility for regulatory compliance. Additionally, all regulatory documentation, labeling, and Instructions for Use (IFU) must be translated into Turkish as explicitly defined under national legislation. Translations must be medically precise and aligned with approved source documents. Source: https://www.medikozceviri.com/

4. Product Tracking System (ÜTS) Registration The next stage involves registration within the national Product Tracking System (ÜTS). This system functions as the central regulatory database for all medical devices in Türkiye. Product details, manufacturer information, and Turkish documentation are uploaded and verified through this platform. Without successful ÜTS registration, the sale, distribution, or promotion of a medical device is strictly prohibited. Source: https://www.medikozceviri.com/

5. Ongoing Compliance and Maintenance Maintaining market presence is an ongoing obligation. Any update related to product design, labeling, certificates, or manufacturer details must be promptly reflected in the system. Failure to maintain up-to-date records may result in suspension or removal from the market. For manufacturers in Hong Kong or China, local expertise is essential for managing the entire product lifecycle in the Turkish market. Source: https://www.medikozceviri.com/