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[AI SaMD Playbook ](/)

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The crosswalk

# One device. Seven regulators. One read.

A side-by-side view of how the major regulators are positioning on AI in Software as a Medical Device. Bookmark it · permalink: /crosswalk .

The crosswalk · preview

## One _device_. Seven regulators. One read.

A condensed view of how the major regulators are positioning on AI in SaMD. Use it to scope your global submission strategy before the divergence multiplies your timeline.

[

FDA 

](/regulators/fda)

[

United States · FDA

Leading 

](/regulators/fda)

[](/regulators/fda)[PCCP](/glossary#pccp) final guidance, AI/ML Action Plan, draft guidance on AI-enabled device software functions.

→ 

[

EU 

](/regulators/eu-ai-act)

[

European Union · AI Act + MDR

Statutory 

](/regulators/eu-ai-act)

[](/regulators/eu-ai-act)[AI Act](/glossary#ai-act) classifies medical AI as high-risk; full obligations apply Aug 2026 alongside [MDR](/glossary#mdr).

→ 

[

MHRA 

United Kingdom · MHRA

Advanced 

Software & AI as a Medical Device Change Programme, AI Airlock sandbox underway.

→ ](/regulators/mhra)

[

HC 

Canada · Health Canada

Advanced 

Pre-market guidance for ML-enabled medical devices; aligned with FDA/MHRA principles.

→ ](/regulators/health-canada)

[

PMDA 

Japan · PMDA

Developing 

IDATEN + Confirmation of Change Plans expanded to AI/program medical devices (Sept 2025).

→ ](/regulators/pmda)

[

TGA 

Australia · TGA

Developing 

Reformed software rules + AI evidence guidance; AI regulation page refreshed Feb 2026.

→ ](/regulators/tga)

[

NMPA 

China · NMPA

Emerging 

Technical review guidelines for AI medical devices; algorithm filing required.

→ ](/regulators/nmpa)

© 2026 AI SaMD Playbook · Sponsored by Blue Goat Cyber

[Crosswalk](/crosswalk)[Colophon](/colophon)

Editorial reference only. Not legal or regulatory advice.