Turkey’s medical device regulatory system is closely aligned with the European Union framework. Market access is mainly based on compliance with MDR 2017/745 and IVDR 2017/746, with CE marking serving as the legal basis for placing medical devices on the Turkish market.

The Turkish Medicines and Medical Devices Agency, TITCK, is the national competent authority, while product registration, UDI information, labeling/IFU files, economic operator records, traceability, and post-market controls are managed through Türkiye’s Product Tracking System, UTS.

Economic operator responsibilities are a key part of the Turkish registration process. For non-Turkish manufacturers, a Türkiye-based Registration Holder / Authorized Representative must be registered in UTS and acts as the legally accountable party.

Turkish MoH applies MDR Annex VIII classification rules without additional national reclassification. Labeling and IFU language requirements vary depending on whether the device is intended for professional users or lay users.

Turkish MoH does not issue a separate physical registration certificate; active UTS registration serves as proof of registration and remains valid as long as the CE certificate or Declaration of Conformity remains valid.

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