The Turkish Medicines and Medical Devices Agency (“TİTCK”) recently published a new Circular on the Product Tracking System (“Circular“) establishing the main principles and procedures for the registration of medical devices and cosmetic products.
What Does the Circular Say?
Last year, the TİTCK launched the Product Tracking System (tr. “ÜTS“), to register, track, and inspect medical devices and cosmetic products produced in or imported to Turkey. The ÜTS opened for the registration of cosmetic products and medical devices on June 12, 2017. The registrations made with the Turkish National Data Bank for Medicines and Medical Devices (tr. TİTUBB) and the Electronic Applications Portal (tr. EUP) must be transferred to the ÜTS by the deadline soon to be determined by the TİTCK.
For the registration of cosmetic products with the ÜTS, the relevant fields were structured in the system to enable cosmetic producers to fulfill their obligations regarding the notification procedures. New cosmetic products entering the market must be registered with the ÜTS and bear a barcode on the packaging. Each product’s barcodes will be registered with the ÜTS separately.
After registering the company records with the ÜTS, medical device manufacturers/importers must register the relevant medical devices with the ÜTS along with their EC certificates, declarations of conformity, labels and other necessary information and documents based on their respective barcodes.
The TİTCK continues to provide guidance on the registration procedures for producers and importers of medical