The Drug and Medical Devices Agency of Turkey (Türkiye İlaç ve Tıbbi Cihaz Kurumu, or TITCK), under the Ministry of Health, is responsible for medical device regulation in Turkey. The medical device regulatory framework is based on
the Turkish Medical Devices Directive (Tibbi Cihaz Yönetmeliği), which is essentially a transposition of the EU Medical Devices Directive MDD 93/42/EEC (as amended by 2007/47/EC).
“Product Tracking System” (ÜTS) is a web based system in which all medical devices and products are expected to be registered with the Ministry of Health (MoH), in accordance with Medical Devices Directive MDD 93/42/EEC (as amended
by 2007/47/EC), “Body Implantable Active Medical Devices Regulation (90/385 / EEC)” and “Turkish Regulation on Medical Diagnostic Devices Used out of Body (In Vitro ( 98/79 / EC). Registration is also required in order to be eligible
for reimbursement.
In June 2017, the Turkish MoH switched their registration system from one database to another. They switched the system from Turkish National Database for Medical devices (TITUBB) to the Product Tracking System (UTS). Registration
in the UTS must be submitted by a local representative in Turkey, who is called the “Registration Holder.” The local representative must be a registered entity in Turkey and must have a company registration in the UTS. Thus, foreign
manufacturers without an establishment in Turkey must appoint an in-country representative to list their devices in the UTS.
What is the Purpose of UTS?
UTS Registration Procedures
Company Registration
For the registration of companies which sell and/or apply medical devices, companies must be authorized according to the relevant legislation. Company registration is done by e-signature of the authorized signatories and/or responsible managers
of the companies. During application, declaration of the ÇKYS (Core Resource Management System) number is mandatory.
Product Registration
Manufacturer and/or importer companies must register each medical device within the scope of “Medical Device Regulations” to the UTS system. In order to register the products, it is necessary to complete the registration of the documents regarding products.Documents to be registered may vary according to product classes. UTS is a dynamic registration system and documentation should be updated when products or documents are updated.
Reimbursement
Manufacturers whose products are eligible for reimbursement must determine the appropriate reimbursement code in the system, and apply for reimbursement.