Medical Devices and Regulatory Affairs in Turkey

Turkey follows the regulations of Europe to fully establish the free movement of Medical devices and In Vitro Diagnostic products, manufactured and sold in Turkey. Medical Devices and In Vito Diagnostic Devices  are regulated in conformity with the European Legislation and shall have CE mark. In addition to the CE mark, the Product Tracking System Project in Turkey aims to develop an infrastructure in order to track medical devices and cosmetic products manufactured or imported. Main Functions of the System is to execute registration processes of medical devices and cosmetic products, to track and recall medical devices and cosmetic products unit or lot based according to decisions, Querying of medical devices and cosmetic products by citizens, to provide advanced reporting capabilities to the stakeholders using the data stored in Product Tracking System, to perform calibration, maintenance and repair operations of medical devices being used settled at hospitals.