South Korea Updates Industrial Standards for Medical Products

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Establishment of 25 Standards (Ministry of Food and Drug Safety (MFDS) Announcement No. 2025-347)

• KS X NEW 2025 2602: Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle

• KS C NEW 2025 4600: Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications

• KS P NEW 2025 2303: Medical devices — Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods


Revision of 77 Standards (MFDS Announcement No. 2025-348)

KS C IEC 60601-1-12: Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment


Abolition of 7 Standards (MFDS Announcement No. 2025-349)

KS P ISO 16971: Ophthalmic instruments — Optical coherence tomograph for the posterior segment of the human eye


Organizations, companies, or individuals wishing to comment on the draft Korean Industrial Standards may submit their opinions to MFDS by October 10, 2025.


GCA Korea provides expert support for global companies navigating South Korea’s regulatory requirements. Our specialties include KC EMC, KC Safety, KC Energy Efficiency, KC Automotive Components, KCsEx (ATEX, IECEx), or MFDS (Korean Medical Devices). For tailored certification and regulatory assistance, contact GCA Korea. We’re here to streamline your market access in South Korea.



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