Cybersecurity Education for Medical Devices: Preparing for Regulatory Changes Ahead

The Ministry of Food and Drug Safety is hosting a series of educational sessions on Medical Device Cyber Security Permit and Review. These sessions are designed to inform medical device manufacturers and review organizations about the necessary cybersecurity documentation and upcoming regulatory changes related to device approval and review.

Program Details:
Objective: To assist participants in preparing and submitting the necessary cybersecurity data for medical device permits and reviews.
Content: The program will cover cybersecurity standards and requirements relevant to medical devices, with a focus on updates between October and December 2024.
Preparation for Future Regulations: This education is in anticipation of the Digital Medical Products Act, set to be enforced in January 2025, and the revision of the Medical Device Cybersecurity Approval and Review Guidelines, due in November 2024.
Session Information:
Dates: The sessions are scheduled three times between October and December 2024.
Capacity: Attendance is limited to 1,000 participants, with spots available on a first-come, first-served basis.
This initiative is designed to ensure that stakeholders are well-prepared for the evolving cybersecurity requirements for medical devices.

Source:https://www.mfds.go.kr/brd/m_99/down.do?brd_id=ntc0021&seq=48591&data_tp=A&file_seq=1

Region: South Korea