PrintOverview:
This report provides a detailed overview of Japan’s most recent medical device regulations from April 2005 to January 2006. This report is 47 pages.
Table of Contents:
- Master File Registration
- Applying for a Foreign Manufacturer Certificate
- New Labeling Requirements
- Licensing System for Medical Device Companies
- New Regulations for Conducting Medical Device Clinical Trials (GCP)
- GCP Compliance Review
- Adverse Events Reporting Requirements
- Information System for Safety Countermeasures
- CHUIKYO: Central Social Insurance Medical Council
- New Requirements for Medical Device Reimbursement
- Post-Marketing Safety Measures (GVP)
- Good Post-Marketing Study Practice (GPSP)
- Standards for Quality Assurance (GQP)
- New GLP Updates
- PMDA Consultations
- Timeline for PMDA Review
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