PrintAs the second largest medical market in the world, Japan is constantly striving to improve its regulatory system to meet demand. Learn more about Japan's medical device regulatory environment and make sure you are prepared. This webcast will delve into various regulatory issues from medical device registration, Foreign Manufacturer Accreditation (FMA), Quality Management System (QMS), and reimbursement. The presenter is Ames Gross, president of Pacific Bridge Medical. There will be a 60-minute presentation followed by a 30-minute Q&A session.
See a sample page of our webcast presentation.
- Overview of Japan's Medical Device Market
- Medical Device Registration
- Required licenses
- Process and timeline
- Application process
- Medical device classifications
- Required documents and information
- Foreign Manufacturer Accreditation (Devices)
- Detailed list of required documents
- Application and review process
- QMS (Quality Management Systems) Audit for devices
- Preparing for your audit (appropriate paperwork, documents, etc.)
- Detailed required documents
- ISO vs QMS
- On-site inspection process
- Tips for success when the PMDA auditors visit
- Device Reimbursement
- How the Japanese reimbursement system works
- Reimbursement classes
- Application process and documents
- Ways to improve pricing
- 2010 Regulatory Updates and New Trends
- New device regulations over last 6 months
- Tips for success
- Cross-cultural issues
This webcast is designed for medical device professionals in regulatory affairs, business development, international sales and marketing, and anyone who wants to be current on Japanese regulatory issues.
This webcast CD includes the audio and PowerPoint presentation.
