Regulation Working Group

Key Stakeholders

Turkish Medicines and Medical Devices Agency (TİTCK), Ministry of Health, Provincial Directorates of the Ministry of Health, Directorate General for International Agreements and EU Affairs at the Ministry of Trade; at the European level: MedTech Europe; regarding customs and import regulations: Directorate General for Customs and Directorate General for Product Safety and Inspection at the Ministry of Trade

Key Topics

Compliance with the EU MDR/IVDR, Product classification and authorization processes, Product Tracking System (ÜTS) and registration procedures, Certification and declaration of conformity, Market surveillance and inspection, Import and domestic production regulations, Obligations of authorized representatives, UDI (Unique Device Identification) applications, Labeling and instructions for use (including e-IFU), Developing industry feedback on regulatory drafts, Technical service and warranty legislation transition timeline and implementation guidance. Contributing to projects aimed at aligning international practices with Turkish regulations is among the working group’s priority actions.