The global nature of the medical device industry presents both opportunities and challenges for medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the US, EU, Canada, Japan, and China. A comparative approach highlights regulatory and process similarities and differences between countries and underscores the impact they have on global regulatory and business strategies. This course will benefit regulatory affairs professionals who need to help their organizations understand the barriers to entry into the global medical device market.

Learning Outcomes

At the conclusion of the course, you should be able to

• Describe what a medical device regulatory strategy is and its elements
• Discuss the various regulatory submission types, their contents, and format
• Explain why a strategy is important and how it drives the business
• Identify common pitfalls of submissions and strategies

Topics Include

• Submission elements
• Regulatory Intelligence
• Interacting with Regulatory Agencies
• Developing a strategy
• A outline for a strategy document