Turkey Regulatory Approval Process for Medical Devices

Download the Regulatory Chart for TurkeyMedical devices in Turkey are governed by the General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device Services. The regulation covering medical devices is the Turkish Medical Devices Directive, which uses the framework of the EU Medical Devices Directive (MDD) 93/42/EEC.

The chart shown illustrates Turkey's approval process and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.

Turkey's medical device approval process explained

Step 1
All medical devices imported into Turkey are required to have European CE marking.* The classification of medical devices is the same used in the EU.

Step 2
Appoint a Turkish Registration Holder (TRH) located in Turkey who will be responsible for registering your product with the Turkish Ministry of Health (MoH).

Step 3
Prepare and send notarized copies of required documents, such as your CE marking certificate and Quality System Certificate, (if applicable) and Declaration of Conformity, to the MoH. Documents must be translated into Turkish by a certified translator.

Step 4
Submit product information to the national database (TITUBB), for review by the MoH. Information required includes: Product Labeling and Instructions for Use (in Turkish), Product Barcodes and Reference Codes, Custom Tariff Number (HS Code), Global Medical Device Nomenclature (GMDN) Code, and more.

Step 5
The MoH will review your application.

Step 6
The MoH does not issue approval certificates, but will publish approvals in the national database. The TITUBB record will serve as proof of registration on the Turkish market, and list the reimbursement code, if applicable.

Step 7
You may now begin marketing your device to public hospitals in Turkey. Registrations are valid for the length of the CE marking certificate; for Class I self-certified products, the registration does not expire.

IMPORTANT: Devices imported into Turkey are required to already have obtained CE Marking. This chart demonstrates the route to compliance in Turkey for devices which already have CE Marking.

* Registration of medical devices with the MoH is required for products which will be sold to public hospitals, in order to be eligible for reimbursement. Registration is recommended for products which are sold to private hospitals or doctors.

© 2015 Emergo Group
Chart updated: 16/04/2015