Labeling Regulation Amendment Overview
TITCK (Türkiye İlaç ve Tıbbi Cihaz Kurumu) published Regulation Amendment No. 2026/11 in the Official Gazette on 12 July 2026, amending the Medical Device Labeling Regulation originally published in 2021. Two principal changes take effect on 01 October 2026: mandatory Turkish-language Instructions for Use and revised electronic IFU carrier requirements for the primary device label.
Turkish-Language IFU Requirement
All medical devices placed on the Turkish market from 01 October 2026 must include a Turkish-language IFU as either a printed document or a validated electronic IFU system. Devices already on the market may continue to be distributed using existing labeling until existing stock is exhausted, provided the device was placed on the market before the effective date. Manufacturers must notify their Turkish authorised representative of the labeling change within 30 days of implementation.
Electronic IFU QR Code Placement
The amendment tightens the placement rules for e-IFU QR codes. Previously, a QR code on outer packaging alone was deemed sufficient. Under the revised regulation, the QR code must appear directly on the primary device label or on a label permanently affixed to the device itself. For devices where label space is insufficient, TITCK will accept an alternative arrangement subject to prior written approval from the agency.
Transition Provisions for e-IFU Systems
Manufacturers currently operating e-IFU systems must submit a Labeling Change Notification to their Turkish authorised representative, who will file a Type IA variation with TITCK. The variation fee is waived for changes made solely to comply with this amendment if submitted before 31 December 2026.