Functioning under the Ministry of Health, the General Directorate of Pharmaceuticals and Pharmacy and Medical Devices (Türkiye İlaç ve Tıbbi Cihaz Kurumu) is responsible for medical device regulations in Turkey. The Directorate regulates drugs, medical and IVD devices, herbal products, dietary supplements, cosmetics and homeopathic medicines. It controls and supervizes the producting, sale, import, export, marketing and distribution of these products.
The regulatory framework is based on the Turkish Medical Devices Directive (Tibbi Cihaz Yönetmeligi, July 7, 2011 Official Gazette, No. 27957), which is a transposition of the EU Medical Devices Directive, MDD 93/42/EEC (as amended by 2007/47/EC).
Some of the most important regulations for medical devices in Turkey are:
The list of Turkey regulations can be found here.
- Website: http://www.iegm.gov.tr/