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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 for the new year. This webcast will provide an overview of Japan’s medical device market, including information on the most recent regulatory issues.
This presentation has 52 slides and the speaker is Ames Gross.
Click here to see a sample page of our webcast presentation.
The following topics are covered in this webcast:
- Overview of Japan and Japan's Medical Device Market
- QMS (Quality Management Systems) Audit
- Preparing for your audit (appropriate paperwork, documents, etc.)
- ISO vs QMS
- Inspection process
- Tips for success
- Foreign Manufacturer Accreditation
- Required documents
- Application and review process
- Reimbursement
- Reimbursement system
- Reimbursement classes
- Application process and documents
- Requirements to Set Up Your Own MAH
- New Consultative Sessions
- How they work
- How much they cost
- How helpful they are
- What is the Best Business Structure for Your Company in Japan
- Representative Office
- Branch Office
- Kabushiki Kaisha (KK)
- Godo Kaisha (GK)
- Advantages and Disadvantages of Each Structure
- Hiring Regulatory People or Regulatory Consulting Firms in Japan
- Where to find regulatory employees/consultants
- What are the salaries and fees
- How to check their backgrounds
- Frequently Asked Questions
- Late 2007 and Early 2008 Regulatory Updates
- Expediting product registration
- Clinical trials
- Japanese Business Culture Issues
- Strategies to succeed with MHLW
Click here to purchase a CD which includes the audio and PowerPoint presentation.
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