Proposed establishment of the "Regulations on the Approval of Clinical Trial protocols and Management of Conducting Clinical Trials for Digital Medical Devices"; (80 page(s), in Korean)

Designation of Shitei Yakubutsu (designated substances), based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the Act). (1960, Law No.145); (1 page(s), in English)

Draft resolution 1224, 11 December 2023; (6 page(s), in Portuguese)