South Korea - Proposed Establishment of the “Regulations on the Approval of Clinical Trial protocols and Management of Conducting Clinical Trials for Digital Medical Devices”

​The Ministry of Food and Drug Safety (MFDS) intends to establish the Regulations on the Approval of Clinical Trial protocols and Management of Conducting Clinical Trials for Digital Medical Devices including the following:

1) Definitions of terms used in the Regulations 

2) Requirements for submission materials for approval applications for clinical trial Protocols

3) Requirements for submission materials for approval applications for conducting clinical trials outside of clinical trial institutions

4) Approval for changes to clinical trial protocols

5) Requirements for preparing clinical performance test protocols

6) Conduct and management of clinical trials and related activities