--- title: "FDA 524B vs MFDS: Cybersecurity Compared" description: "United States vs South Korea medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. MFDS's 2024 cybersecurity notificati" lang: en json-ld: | [ { "@context": "https://schema.org", "@type": "WebSite", "name": "The Medical Device Cybersecurity Crosswalk", "alternateName": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "description": "Compare FDA, EU MDR, MHRA, PMDA, NMPA, TGA, MFDS and Health Canada medical device cybersecurity requirements across 29 jurisdictions." }, { "@context": "https://schema.org", "@type": "Organization", "name": "MDC Crosswalk", "url": "https://mdccrosswalk.com/", "logo": "https://mdccrosswalk.com/favicon.png", "sameAs": [ "https://bluegoatcyber.com" ], "description": "An editorial reference comparing global medical-device cybersecurity regulations. Maintained by Blue Goat Cyber." }, { "@context": "https://schema.org", "@type": "Article", "headline": "FDA 524B vs MFDS: Medical Device Cybersecurity Compared", "description": "United States vs South Korea medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. MFDS's 2024 cybersecurity notification is broadly aligned to FDA §524B at the pr…", "about": [ "U.S. Food and Drug Administration, Center for Devices and Radiological Health", "Ministry of Food and Drug Safety" ], "author": { "@type": "Organization", "name": "MDC Crosswalk" }, "publisher": { "@type": "Organization", "name": "MDC Crosswalk" }, "mainEntityOfPage": "https://mdccrosswalk.lovable.app/compare/fda-vs-mfds" }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "Does MFDS accept FDA clearance?", "acceptedAnswer": { "@type": "Answer", "text": "Not as a substitute. MFDS runs its own review and requires Korean-language documentation, K-GMP audit, and a Korean Licence Holder. FDA evidence accelerates the technical review but doesn't shortcut the regulatory pathway." } }, { "@type": "Question", "name": "What's special about MFDS AI/ML expectations?", "acceptedAnswer": { "@type": "Answer", "text": "MFDS's 2023 AI/ML addendum requires a change-control plan in the submission - similar in spirit to FDA's Predetermined Change Control Plan but with Korean-specific labelling for AI-driven outputs." } } ] }, { "@context": "https://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://mdccrosswalk.lovable.app/" }, { "@type": "ListItem", "position": 2, "name": "Compare", "item": "https://mdccrosswalk.lovable.app/compare" }, { "@type": "ListItem", "position": 3, "name": "FDA 524B vs MFDS" } ] } ] --- [ The Crosswalk ](/) [Overview](/)[Playbook](/playbook)CompareReference [New Per-page social previews and this changelog ](/changelog "Per-page social previews and this changelog") Search⌘K 1. [Home ](/) 2. [Compare](/compare) 3. FDA 524B vs MFDS Head to head # ![Flag of United States](/flags/us.svg) FDA 524Bvs ![Flag of South Korea](/flags/kr.svg) MFDS United States and South Korea medical-device cybersecurity, compared. Last updated · July 25, 2026 Share Copy link X LinkedIn Email Bottom line MFDS's 2024 cybersecurity notification is broadly aligned to FDA §524B at the principles level - same lifecycle expectations, same threat-model and SBOM logic. Plan on ~65% reuse: the real costs are Korean-language documentation, a Korean Licence Holder (KLH), K-GMP audit, and the 5-year periodic review unique to Korea. Who this is for · US-cleared sponsors planning a Korean MFDS submission. ## Where they differ Cyber guidance ![Flag of United States](/flags/us.svg) FDA 524B FDA Final Guidance (Feb 2026). ![Flag of South Korea](/flags/kr.svg) MFDS MFDS Cybersecurity Review Guideline (rev 2024). Takeaway Same principles; MFDS adds an AI/ML-specific addendum. SBOM ![Flag of United States](/flags/us.svg) FDA 524B Mandatory (machine-readable). ![Flag of South Korea](/flags/kr.svg) MFDS Recommended; aligns to IMDRF N60. Takeaway Single CycloneDX file works for both filings. QMS ![Flag of United States](/flags/us.svg) FDA 524B QMSR (ISO 13485:2016). ![Flag of South Korea](/flags/kr.svg) MFDS K-GMP audit (separate from MDSAP). Takeaway K-GMP is Korea-specific; MDSAP is not accepted. Periodic review ![Flag of United States](/flags/us.svg) FDA 524B None. ![Flag of South Korea](/flags/kr.svg) MFDS 5-year re-evaluation required. Takeaway Budget for a recurring cyber-evidence refresh every 5 years. [ Full profile ### ![Flag of United States](/flags/us.svg)United States FDA Premarket Cybersecurity Guidance & FD&C §524B Open profile ](/standards/fda)[ Full profile ### ![Flag of South Korea](/flags/kr.svg)South Korea Cybersecurity Review Guideline for Medical Devices Open profile ](/standards/kr) ## Frequently asked ### Does MFDS accept FDA clearance? Not as a substitute. MFDS runs its own review and requires Korean-language documentation, K-GMP audit, and a Korean Licence Holder. FDA evidence accelerates the technical review but doesn't shortcut the regulatory pathway. ### What's special about MFDS AI/ML expectations? MFDS's 2023 AI/ML addendum requires a change-control plan in the submission - similar in spirit to FDA's Predetermined Change Control Plan but with Korean-specific labelling for AI-driven outputs. ## Other head-to-heads [FDA 524B vs EU MDR](/compare/fda-vs-eu-mdr)[FDA 524B vs PMDA](/compare/fda-vs-pmda)[FDA 524B vs MHRA](/compare/fda-vs-mhra)[FDA 524B vs Health Canada](/compare/fda-vs-health-canada)[FDA 524B vs NMPA](/compare/fda-vs-nmpa)[EU MDR vs MHRA](/compare/eu-mdr-vs-uk-mhra)[EU MDR vs PMDA](/compare/eu-mdr-vs-pmda)[EU MDR vs Health Canada](/compare/eu-mdr-vs-health-canada)[FDA 524B vs TGA](/compare/fda-vs-tga) Sponsored note · Blue Goat Cyber Submitting in both United States and South Korea? Blue Goat Cyber has prepared cybersecurity evidence for both markets dozens of times. We'll map your existing package against both, in one 30-minute review. [Talk through your dual submission](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) The Crosswalk An independent reference for global medical device cybersecurity standards. A field guide for MedTech innovators and RA/QA teams charting an international path. Resource - [Comparison matrix](/compare) - [Global playbook](/playbook) - [Glossary](/glossary) - [FAQ](/faq) Sponsored by [Blue Goat Cyber ↗](https://bluegoatcyber.com) Editorially independent. Sponsorship keeps it free. © 2026 The Crosswalk. Not legal advice. Validate every requirement against current regulator publications.