Global Medical Device Cybersecurity Regulations & Guidances
This article lists key medical device cybersecurity regulations and guidance from major regulatory regions worldwide. Organizations working on bringing new medical devices containing software or firmware may be required to comply with one or more of these based on the country they are expected to be marketed.
| Document Title | Year | Country / Region | Description |
|---|---|---|---|
| Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Final Guidance) | June 2025 | United States (FDA) | The 2025 FDA guidance update adds new statutory provisions under section 524B of the FD&C Act. |
| Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity IMDRF/CYBER WG/N73 FINAL:2023 (Edition 1) | Apr 2023 | IMDRF | Provides recommendations for medical device manufacturers in SBOM generation, management, and distribution. Also includes healthcare provider recommendations / use cases. |
| Principles and Practices for the Cybersecurity of Legacy Medical Devices IMDRF/CYBER WG/N70 FINAL:2023 (Edition1) | Apr 2023 | IMDRF | Explain legacy medical device in the context of TPLC, provide recommendations for MDMs and healthcare providers. |
| Federal Food, Drug, and Cosmetic Act (FD&C Act) section 524B, Ensuring Cybersecurity of Devices. | Dec 2022 | United States (FDA) | On December 29, 2022, the Consolidated Appropriations Act, 2023 (“Omnibus”) was signed into law amending FD&C Act to add section 524B. |
| Principles and Practices for Medical Device Cybersecurity IMDRF/CYBER WG/N60FINAL:2020 | April 2020 | IMDRF | Provides general principles and best practices to facilitate international regulatory convergence on medical device cybersecurity. |
| Postmarket Management of Cybersecurity in Medical Devices (Guidance) | 2016 | United States (FDA) | FDA postmarket cybersecurity guidance |
| Regulation (EU) 2017/745 on Medical Devices (MDR) | 2017 | European Union | MDR includes cybersecurity requirements in risk management Annex I §17.4 |
| Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | 2017 | European Union | IVDR imposes cybersecurity obligations similar to MDR |
| Guidance of cybersecurity for medical devices | July 2020 | European Union | Provides manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity. |
| Regulation (EU) 2024/2847 – Cyber Resilience Act | 2024 (comes into force 2027) | European Union | Horizontal cybersecurity regulation covering digital products, including medical devices with digital elements |
| Directive (EU) 2022/2555 – NIS 2 Directive | 2023 | European Union | Expands healthcare and medical‑device manufacturer obligations for cybersecurity risk management and incident reporting |
| Management of Vulnerabilities to Ensure Cybersecurity of Medical Devices English Translation | March 2024 | Japan (MHLW) | Notification on post market management of vulnerabilities by manufacturers |
| Essential Requirements – Article 12 Clause 3 on Cybersecurity Presentation Deck English Translation Confirmation of Compliance English Translation | 2023 | Japan (MHLW/PMDA) | Amendment requiring compliance with JIS T 81001‑5‑1 for internet‑connected medical device software; enforcement began April 1, 2023 |
| “Ensuring Cyber Security of Medical Devices” Notification (MHLW) | 2015 | Japan | Initial notification on evaluating cybersecurity risk for devices |
| Guidance on Ensuring Cyber Security of Medical Devices (MHLW) | 2018 | Japan | Practical guidance for pre‑market design and post‑market cybersecurity risk management |
| Complying with Medical Device Cyber Security Requirements Guidance (Web link) | 2022 (updated Oct 2025) | Australia (TGA) | TGA guidance |
| Best Practices Guide for Medical Device Cybersecurity (Draft) | 2025 (draft) | Singapore (HSA/CSA) | Public consultation document, comment period closed in May 2025 |
| Cybersecurity Labelling Scheme for Medical Devices (CLS MD) | 2024 | Singapore (CSA/MOH/HSA) | Voluntary multi‑level label scheme for medical devices |
| Guidelines for the Security Assessment of Medical Devices | 2020 | China (NMPA/CAC) | Cybersecurity assessment methodology for registration |
| Medical Device Cybersecurity Vulnerability Identification & Assessment Methodology (Draft) | 2022 | China (State Drug Administration) | Published draft methodology in Nov 2022 |
| Guidance Document: Pre-market Requirements for Medical Device Cybersecurity (Web Link) | 2019 | Canada (Health Canada) | Health Canada pre-market cybersecurity guidance |
| Principles and Practices of Cyber Security in Medical Devices (Guide No. 38/2020) | 2020 | Brazil (GGTPS) | Brazil has adopted the IMDRF guidance in this guide produced by the General Management of Health Products Technology (GGTPS). |
| Cyber Security Requirements for Network-Connected Medical Devices (Web Link) | 2018 | Germany (BSI) | Recommendations to meet Medical Device Directive (MDD), which is now superseded by EU MDR. |
| MHRA & UK – Good Machine Learning Practice & Transparency Principles | 2024 | United Kingdom (UH MHRA) | Joint GMLP / transparency principles for ML‑enabled devices |
- United States: The 2025 FDA final guidance adds new statutory provisions under section 524B of the FD&C Act.
- European Union: The MDR and IVDR embed cybersecurity requirements, while the NIS 2 and Cyber Resilience Act expand obligations for manufacturers and software products.
- Japan: Starting from 2015, Japan developed formal requirements culminating in 2023 with mandatory cybersecurity conformance to JIS T 81001-5-1.
Last updated: October 2025