Substantial Change/Amendment applications for commercial applications (sponsored by a commercial company) initially submitted through the "Medical Device Clinical Trials and In Vitro Performance Studies Application Modules" within our institution's Electronic Application and Process Management System (EBS-ESY) will be accepted through the "Amendment Application" heading under the relevant modules. These applications will not be considered if submitted through the "Applications - General Document Application" screen.

Important Change/Amendment applications for old applications made before 01.01.2025, the first application of which was not made through the module, will be made through the "Applications-General Document Application" screen.

Note: The change application screen will be activated on 15.12.2025.