Course Content

6 International Regulation: Europe and Japan

Course Overview

1 Introduction

2 Safety & Effectiveness

3 Regulatory Pathways

4 Clinical Trials

5 Quality Systems

• 6 Intl Regulation

Video
Slides
Quiz
Worksheet
References

References

Glossary

Summary

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What you will learn in this section

• How are medical devices regulated in the European Union?
  
• Statutory background and involved entities
• Medical Device Directives
  
• Classification System
  
• Regulatory Pathways
• How are medical devices regulated in Japan?
  
• Statutory Background and involved entities
• Classification System
• Regulatory Pathways

Content

Play video

1. Jan Pietzsch on International Regulation of Medical Devices

Slides (PDF)

Speakers Biographies

Jan Pietzsch

Additional Materials

Assessment Quiz

Worksheet (pdf)

References (doc)