South Korea - Partial Amendment to the Regulation on Medical Device Approval, Notification, and Review

​This amendment aims to clarify the requirements for submitting cybersecurity documentation for medical devices that use wired or wireless communication and to add clinical trial documentation requirements in alignment with international standards. 

Additionally, it seeks to address certain deficiencies identified in the system's operational aspects.

- Establish procedures for applying for approval and certification to defer new medical technology evaluation.

- Streamline tasks related to the certification of Class 2 medical devices.

- Clarify the acceptance procedure for medical device manufacturing and import notifications.

- Specify regulations for submitting cybersecurity review documentation for medical devices.

- Prepare support measures for the approval and review of newly developed medical devices.

- Improve the scope of documentation submissions, such as technical documents, by providing examples, etc.