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)

Resolution number 629, 10 March 2022; (6 page(s), in Portuguese)

Proposed amendments to the "Regulation on the Permission, Notification, Review, etc of Medical Devices"; (51 page(s), in Korean)