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International Medical Device Regulators Forum

# IMDRF N60

[Source](https://www.imdrf.org/documents/principles-and-practices-medical-device-cybersecurity)

Principles & practices for medical device cybersecurity

Last updated · July 25, 2026 

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## What it is

Voluntary, harmonised guidance covering the total product life cycle. Acts as the reference point most national regulators map to.

## Why it matters

If you design to N60, you have a credible story in the FDA, Health Canada, PMDA, TGA, MFDS, HSA and SFDA submissions. It is the single biggest leverage point for global cybersecurity strategy.

## Adopted or referenced by

FDA  Health Canada  PMDA  TGA  MFDS  HSA  SFDA  ANVISA 

Verified adoption · self-reported by regulators

## Implementation status across IMDRF members

[IMDRF/MC/N84 FINAL:2025 (Edition 2) · 1 September 2025](https://www.imdrf.org/sites/default/files/2025-09/IMDRF%20Document%20Implementation%20Report%201September2025_0.pdf)

8 of 14 regulators report full implementation. 4 partial. 2 not yet.

Implemented

8 

-   Australia
-   Brazil
-   Canada
-   EU
-   South Korea
-   Singapore
-   Switzerland
-   USA

Partly implemented

4 

-   China
-   Japan
-   Russia
-   Saudi Arabia

Not implemented

2 

-   UK
-   Argentina

Status reported by each regulator to IMDRF as of 1 September 2025. "Implemented" means all relevant elements, concepts and principles of the IMDRF document are followed; "partly" means modified or applied to a narrower product range. Source: [IMDRF/MC/N84 FINAL:2025 (Edition 2)](https://www.imdrf.org/sites/default/files/2025-09/IMDRF%20Document%20Implementation%20Report%201September2025_0.pdf).

## Key clauses

Shared responsibility

Manufacturers, healthcare providers and users share security obligations through the lifecycle.

Information sharing

CVD programs and ISAO membership recommended.

TPLC

Pre-market AND post-market activities are mandatory components of any conformity story.

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An independent reference for global medical device cybersecurity standards. A field guide for MedTech innovators and RA/QA teams charting an international path.

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