--- title: "FDA 524B vs PMDA: Cybersecurity Compared" description: "United States vs Japan medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. PMDA's 2024 cybersecurity guidance is the" 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 PMDA: Medical Device Cybersecurity Compared", "description": "United States vs Japan medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. PMDA's 2024 cybersecurity guidance is the closest international mirror of FDA §5…", "about": [ "U.S. Food and Drug Administration, Center for Devices and Radiological Health", "Pharmaceuticals and Medical Devices Agency / Ministry of Health, Labour and Welfare" ], "author": { "@type": "Organization", "name": "MDC Crosswalk" }, "publisher": { "@type": "Organization", "name": "MDC Crosswalk" }, "mainEntityOfPage": "https://mdccrosswalk.lovable.app/compare/fda-vs-pmda" }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "How much of my FDA package is reusable in Japan?", "acceptedAnswer": { "@type": "Answer", "text": "Roughly 85%. The threat model, SBOM, security risk analysis, and pen-test report transfer directly. You'll add Japanese-language summaries, MAH attestations, and JIS T 81001-5-1 conformity references." } }, { "@type": "Question", "name": "Does PMDA accept FDA clearance as a shortcut?", "acceptedAnswer": { "@type": "Answer", "text": "No - Japan requires its own Shonin approval or third-party certification. But cybersecurity evidence travels well, and PMDA reviewers explicitly cite FDA alignment as a maturity signal." } } ] }, { "@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 PMDA" } ] } ] --- [ 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 PMDA Head to head # ![Flag of United States](/flags/us.svg) FDA 524Bvs ![Flag of Japan](/flags/jp.svg) PMDA United States and Japan medical-device cybersecurity, compared. Last updated · July 25, 2026 Share Copy link X LinkedIn Email Bottom line PMDA's 2024 cybersecurity guidance is the closest international mirror of FDA §524B - same SPDF logic, same SBOM expectation, same lifecycle commitments. The differences are language (Japanese-language IFU/labelling and a Japanese MAH), QMS overlay (PMD Act + Ordinance 169), and the use of JIRA / IMDRF N60 as the harmonisation anchor. Who this is for · US-cleared sponsors planning Shonin or third-party certification in Japan. ## Where they differ Lifecycle expectation ![Flag of United States](/flags/us.svg) FDA 524B SPDF under QMSR. ![Flag of Japan](/flags/jp.svg) PMDA PMDA guidance + JIS T 81001-5-1 alignment. Takeaway Identical content, mapped to Japan-specific standards. SBOM ![Flag of United States](/flags/us.svg) FDA 524B Mandatory machine-readable. ![Flag of Japan](/flags/jp.svg) PMDA Mandatory under 2024 PMDA notification. Takeaway One CycloneDX file covers both. Local rep ![Flag of United States](/flags/us.svg) FDA 524B U.S. agent for foreign manufacturers. ![Flag of Japan](/flags/jp.svg) PMDA Marketing Authorisation Holder (MAH) in Japan. Takeaway MAH must hold the technical documentation including your cyber file. Language ![Flag of United States](/flags/us.svg) FDA 524B English. ![Flag of Japan](/flags/jp.svg) PMDA Japanese IFU and labelling mandatory. Takeaway Translation cost is the predictable extra line item. [ 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 Japan](/flags/jp.svg)Japan PMSD Act + MHLW Cybersecurity Notifications (2023–24) Open profile ](/standards/jp) ## Frequently asked ### How much of my FDA package is reusable in Japan? Roughly 85%. The threat model, SBOM, security risk analysis, and pen-test report transfer directly. You'll add Japanese-language summaries, MAH attestations, and JIS T 81001-5-1 conformity references. ### Does PMDA accept FDA clearance as a shortcut? No - Japan requires its own Shonin approval or third-party certification. But cybersecurity evidence travels well, and PMDA reviewers explicitly cite FDA alignment as a maturity signal. ## Other head-to-heads [FDA 524B vs EU MDR](/compare/fda-vs-eu-mdr)[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)[FDA 524B vs MFDS](/compare/fda-vs-mfds) Sponsored note · Blue Goat Cyber Submitting in both United States and Japan? 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.