Cybersecurity in the Medical Device
The Ministry of Food and Drug Safety and the Korea Internet & Security Agency agreed to extend their memorandum of understanding (MOU) for two more years on May 26. This MOU aims to strengthen cooperation in managing safety against cybersecurity threats such as hacking and information leakage in medical devices that utilize information and communication technology.
The extension of this agreement aims to further strengthen the cooperation that has been ongoing for four years since 2020, following the mandatory submission of cybersecurity data during the approval and certification of medical devices in November 2019. The key points of the agreement are as follows.
• Support for testing and research to strengthen the security of medical devices
• Cooperation in developing new security models
• Consultation on analyzing and responding to security incidents
• Joint hosting of security education seminars and symposiums
• Sharing of knowledge, information, and materials related to security
During this time, the two agencies have aimed to enhance the industry's capabilities through cybersecurity briefings and have supported security vulnerability checks and tailored consultations for 23 products, including robotic surgical devices. Additionally, by recognizing IoT security certificates tested and certified by the Korea Internet & Security Agency, they have shortened the approval and certification review period for medical devices.
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