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)

Draft Amendments to Article 7 and to the Annex to Article 4 of the "Regulations Governing the Classification of Medical Devices"; (43 page(s), in English), (27 page(s), in Chinese)

Proposed partial amendments to the Regulation on medical device approval/report/review, etc.; (18 page(s), in Korean)