South Korea - Proposed Establishment of the “Guidelines for Security Against Electronic Intrusion in Digital Medical Devices”

The Ministry of Food and Drug Safety (MFDS) intends to establish the Guidelines for Security Against Electronic Intrusion in Digital Medical Devices  including the following:

1) Security activities and documentation

2) Physical security system

3) Technical security system

4) Risk management

5) Vulnerability Monitoring and Response

6) Re-review Deadline