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Reading the MFDS Medical Device Cybersecurity Guideline — Guidance No. 0995-05
An explanation of the MFDS medical device cybersecurity approval/review guideline (Guidance No. 0995-05, 2025.01.10) on the basis of IEC 62443-4-2. It organizes, from the perspective of regulatory practitioners and developers, the structure of the 35 requirements across 6 categories, the mapping to the IEC 62443 FR/CR system, the approval submission requirements, and the transition schedule before and after revision.
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