global-regulatory-pathways

Name: global-regulatory-pathways
Author: alirezarezvani

International regulatory requirements for medical devices beyond FDA and EU MDR markets.

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# Global Regulatory Pathways

International regulatory requirements for medical devices beyond FDA and EU MDR markets.

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## Table of Contents

- [Canada (Health Canada)](#canada-health-canada)
- [Japan (PMDA)](#japan-pmda)
- [China (NMPA)](#china-nmpa)
- [Australia (TGA)](#australia-tga)
- [Brazil (ANVISA)](#brazil-anvisa)
- [Market Entry Strategy](#market-entry-strategy)

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## Canada (Health Canada)

### Device Classification

| Class | Risk Level | Examples | Review Type |
|-------|----

How to Use

Recommended: Install to project (local)

mkdir -p .claude/skills
curl -o .claude/skills/global-regulatory-pathways.md \
  https://raw.githubusercontent.com/alirezarezvani/claude-skills/main/ra-qm-team/regulatory-affairs-head/references/global-regulatory-pathways.md

Skill is scoped to this project only. Add .claude/skills/ to your .gitignoreif you don't want to commit it.

Alternative: Clone full repo

git clone https://github.com/alirezarezvani/claude-skills

Then reference at ra-qm-team/regulatory-affairs-head/references/global-regulatory-pathways.md