PrintThis webcast CD provides an overview of Japan's most recent medical device regulations post April 1, 2005. All new regulatory material presented will cover issues from April 2005 to January 2006. This Japan presentation has 82 PowerPoint slides and the speaker is Ames Gross.
See a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Overview of Japan ’s healthcare system
- Application requirements to get import/export permits for medical devices
- Classification of medical devices
- List of medical devices subject to government regulation
- Medical device registration requirements
- Procurement practices and types of tenders
- Postmarket and surveillance requirements
- New PMDA consultations for clinical trials
- New adverse event reporting requirements
- New standards for quality assurance (QA)
- Other new regulations
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, or anyone who wants to be current on a number of new Japanese regulatory issues.
The presenter, Mr. Ames Gross, is president and founder of Pacific Bridge Medical (PBM). Established in 1988, PBM is a consulting company that has assisted over 200 medical companies with regulatory and business development issues in Asia. Prior to establishing PBM, Mr. Gross gained broad experience, knowledge, and contacts in Asia while working at three major Wall Street firms where he consummated over $500 million dollars of U.S. - Asian transactions. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
