The Processes in Medical Device Clinical Investigations

Abstract

Turkey will be carried out in the medical device clinical investigation from the Ministry of Health to initiate Turkey Medicine and Medical Devices Agency (TİTCK) should be approved. Applications are evaluated within the scope of the Medical Device Clinical Investigation Regulation published in the Official Gazette dated 06.09.2014 and numbered 29111, and the In Vitro Diagnostic Medical Device Regulation and the Medical Device Regulation published in the Official Gazette dated 02.06.2021 and numbered 31499 (repetitive). In this paper, developments in medical device clinical trials from past to present, legally binding documents, and application processes were evaluated. It has been determined that there is no obstacle to the initiation and conducting of medical device clinical trials in our country.