The Turkish Medicines and Medical Devices Agency (the “Agency”) has announced new notification obligations for economic operators in the event of an interruption or discontinuation (termination) of the supply of medical devices. This regulation was developed in line with the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, which were enacted as part of the European Union (“EU”) harmonization process and was published on May 21, 2025.
According to the Agency’s announcement, any anticipated supply interruptions or discontinuations of medical devices or in vitro diagnostic devices must be reported to the Agency in advance. This obligation applies to products that may pose serious risks or reasonably foreseeable risks to patients and public health.
All manufacturers are required to notify Agency at least six months prior to the planned date of supply discontinuation. This notification obligation applies both to manufacturers established in Turkey and to authorized representatives of foreign manufacturers operating in Turkey.
On the other hand, manufacturers established in EU member states will report such information to the competent authorities in their own countries, and therefore importers in Turkey are not required to submit a separate notification. However, if the supply interruption is to occur only within Turkey’s borders, importers are also obliged to notify Agency accordingly.
The required documents for notification must be prepared in both Turkish and English and submitted to the Agency both via email (kbb2@titck.gov.tr) and through the Agency’s EBS system as an official application.
This new regulation is considered an important step toward ensuring uninterrupted supply of medical devices; by anticipating potential supply disruptions of critical products and informing relevant public authorities, the resilience of the healthcare system is strengthened. Furthermore, this practice demonstrates Turkey’s commitment to harmonization with EU legislation.
In conclusion, it is of vital importance that all companies operating in the medical device sector give utmost attention to these new obligations and complete the notification processes timely and accurately.
Author:
Dicle Doğan, Managing Associate
dicle.dogan@gun.av.tr