Proposed amendments to the "ENFORCEMENT DECREE OF THE PHARMACEUTICAL AFFAIRS ACT"; (3 page(s), in Korean)

Draft FDA Circular entitled "Abridged Processing of Application for Registration/Notification of Medical Devices Approved by National Regulatory Authority of Any ASEAN Member Country"; (4 page(s), in English)

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)