South Korea - Administrative Notice for the Partial Revision of the "Regulations on Medical Device Approval, Notification, and Review"

The administrative notice for the partial revision of the "Regulations on Medical Device Approval, Notification, and Review" aims to inform the public and gather opinions on proposed changes. Key details include:

- To clarify requirements for submitting cybersecurity documentation for medical devices using wired or wireless communication.

- To align clinical trial documentation requirements with international standards.

- To address and improve shortcomings observed in the current system’s operation.