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)

Proposed establishment of the "Regulations on the Approval, Certification, Notification, Review, and Evaluation of Digital Medical Products"; (94 page(s), in Korean)

Administrative Provisions for the Record-filing of Internet Information Services for Drug and Medical Devices (Exposure Draft); (5 page(s), in Chinese)