--- title: "FDA 524B vs TGA: Cybersecurity Compared" description: "United States vs Australia medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. TGA's 2024 cybersecurity guidance v2 i" 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 TGA: Medical Device Cybersecurity Compared", "description": "United States vs Australia medical-device cybersecurity: SBOM, threat modeling, post-market and penalties side by side. TGA's 2024 cybersecurity guidance v2 is closely aligned to FDA §524B - both refe…", "about": [ "U.S. Food and Drug Administration, Center for Devices and Radiological Health", "Therapeutic Goods Administration" ], "author": { "@type": "Organization", "name": "MDC Crosswalk" }, "publisher": { "@type": "Organization", "name": "MDC Crosswalk" }, "mainEntityOfPage": "https://mdccrosswalk.lovable.app/compare/fda-vs-tga" }, { "@context": "https://schema.org", "@type": "FAQPage", "mainEntity": [ { "@type": "Question", "name": "Is Australia the easiest second market after Canada for FDA-cleared devices?", "acceptedAnswer": { "@type": "Answer", "text": "It's competitive. Canada wins on volume of cybersecurity reuse (~95%) and English-only labelling. Australia wins on MDSAP convergence and a single-Sponsor model. Most sponsors file both in parallel." } } ] }, { "@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 TGA" } ] } ] --- [ 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 TGA Head to head # ![Flag of United States](/flags/us.svg) FDA 524Bvs ![Flag of Australia](/flags/au.svg) TGA United States and Australia medical-device cybersecurity, compared. Last updated · July 25, 2026 Share Copy link X LinkedIn Email Bottom line TGA's 2024 cybersecurity guidance v2 is closely aligned to FDA §524B - both reference IMDRF N60, both expect SPDF-style lifecycle evidence, both want an SBOM. An FDA cybersecurity package is roughly 85% reusable. The additions are an Australian Sponsor, MDSAP-aligned QMS, and TGA's specific essential-principles documentation format. Who this is for · US-cleared sponsors planning Australian TGA Conformity Assessment. ## Where they differ Legal anchor ![Flag of United States](/flags/us.svg) FDA 524B FD&C §524B. ![Flag of Australia](/flags/au.svg) TGA Therapeutic Goods (Medical Devices) Regulations 2002 + TGA cyber guidance v2 (2024). Takeaway Both are mandatory; TGA leans heavily on IMDRF harmonisation. SBOM ![Flag of United States](/flags/us.svg) FDA 524B Mandatory (SPDX or CycloneDX). ![Flag of Australia](/flags/au.svg) TGA Expected for connected devices; same format accepted. Takeaway Single SBOM serves both submissions. QMS ![Flag of United States](/flags/us.svg) FDA 524B QMSR / ISO 13485:2016. ![Flag of Australia](/flags/au.svg) TGA MDSAP or ISO 13485:2016. Takeaway MDSAP audit covers FDA + TGA + 3 others in one pass. Local presence ![Flag of United States](/flags/us.svg) FDA 524B U.S. agent. ![Flag of Australia](/flags/au.svg) TGA Australian Sponsor with regulatory liability. Takeaway Sponsor liability is broader than a U.S. agent's. [ 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 Australia](/flags/au.svg)Australia Medical Device Cybersecurity Guidance Open profile ](/standards/au) ## Frequently asked ### Is Australia the easiest second market after Canada for FDA-cleared devices? It's competitive. Canada wins on volume of cybersecurity reuse (~95%) and English-only labelling. Australia wins on MDSAP convergence and a single-Sponsor model. Most sponsors file both in parallel. ## 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 MFDS](/compare/fda-vs-mfds) Sponsored note · Blue Goat Cyber Submitting in both United States and Australia? 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.