Turkey Medical Device Regulations

All documents here were published by the General Directorate of Pharmaceuticals and Pharmacy and Medical Devices, under the Turkish Ministry of Health (MOH), and are in PDF format. The regulatory framework is based on the Turkish Medical Devices Directive, which is a transposition of the EU Medical Devices Directive MDD 93/42/EEC (as amended by 2007/47/EC).

Major Regulations

Medical Devices Directive (Turkish) 2795706/2011

General Guidance Documents

Announcement for Manufacturers, Importers, and Dealers (Turkish) 129201/2013