NLMedicalDevices object

Applicable national regulations

National Act on Medical Devices
Other

Act on Medical Devices (or comparable national legal framework)

Regulation On Medical Device Clinical Trials, No. 29111 of the Official Gazette, September 6, 2014 (available in Turkish only).
This Regulation is issued based on Supplemental Article 10 of Fundamental Law #3359 dated 07.05.1987 on Health Services and Articles 27 and 40 of Decree Law #663 on the Organization and Mandate of the Ministry of Health and Its Subordinate Agencies. Retrospective studies and performance assessment studies involving use of in vitro medical diagnosis devices are outside the scope of this Regulation.

Additional Information

Please refer to the Guideline for Good Clinical Practice (2014) for general principles regarding clinical trials. Guidelines on other relevant topics are also provided by the Ministry.

An overview on the current legislation related to the conduct of clinical trials in Turkey has been recently published and is publicly available:
Ilbars H. Clinical Trials in Turkey. Turk J Haematol 2013;30:111–114

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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