Global Medical Device Submissions and Strategy | REGL.X401

Global Medical Device Submissions and Strategy | REGL.X401

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
  • Developing a strategy
  • A outline for a strategy document

Next Section Starts In:


June 8, 2024, 8:30 a.m.
Have a question about this course?
Speak to a student services representative.
Call (408) 861-3860
This course is related to the following programs:

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Quarter Units Cost Instructor
06-08-2024 to 06-22-2024 1.5 $750

Patrick Lee


Final Date To Enroll: 06-08-2024


Date: Start Time: End Time: Meeting Type: Location:
Sat, 06-08-2024 8:30 a.m. 5:00 p.m. Live-Online REMOTE
Sat, 06-15-2024 9:00 a.m. 12:00 p.m. Live-Online REMOTE
Sat, 06-22-2024 9:00 a.m. 12:00 p.m. Live-Online REMOTE