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Updates on Japan's Expanding Medical Device Market
Pacific Bridge Medical, May 2009
As the second largest medical market in the world, Japan is constantly striving to improve its regulatory system to meet demand. New consultation sessions, plans to increase staff and reviewers, and goals to enforce shorter review times are just some of the new changes Japan�s Pharmaceuticals and Medical Devices Agency is implementing. Learn more about Japan�s medical device regulatory environment and make sure you are prepared. This webcast will provide an overview of Japan�s medical device market, including information on the most recent regulatory issues. The presenter is Ames Gross, president of Pacific Bridge Medical.
The following topics will covered in this webcast:
- Overview of Japan's Medical Device Market
- Foreign Manufacturer Accreditation
- - Required documents
- - Application and review process
- QMS (Quality Management Systems) Audit
- - Preparing for your audit (appropriate paperwork, documents, etc.)
- - Document requests
- - ISO vs QMS
- - Inspection process
- - Tips for success
- Reimbursement
- - How the reimbursement system works
- - Reimbursement classes
- - Application process and documents
- - Ways to improve pricing
- 2009 Regulatory Updates and New Trends
- - Expediting product registration
- - Updated medical device review fees
- - Partial change amendments
- - GCP new regulations
- - Return of me-too applications
- - Smaller businesses able to access Japan market again
- Frequently Asked Questions
- - Distributor change/MAH change
- - Communication issues with Japan office
- - How to make sure product registration go smoothly
- - and more
- New Consultative Sessions
- - How they work
- - How much they cost
- - How helpful they are
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