PrintOverview:
Recently, Western medical device manufacturers have had to comply with Japan's Quality Management System (QMS) standards to register and sell their products in Japan. Pacific Bridge Medical's new report is the only comprehensive English guide to the new Japanese quality audits, including official quality system requirements, documents needed, tips for success, and translations of key Japanese regulations.
Help your company pass its PMDA audit the first time with this comprehensive report. The report is 35 pages, plus an additional 61-page appendix.
Table of Contents
- Introduction
- Registration Overview
- Registration system
- Audits and how they fit into registration
- Foreign Manufacturer Accreditation (FMA)
- Overview and scope of FMA
- Categorization of devices under FMA
- Documents to submit for FMA
- Application and review process
- Changes or additions
- QMS Compliance Audit
- Introduction
- General information
- Determination of on-site vs. paper audit
- Paper audit details
- On-site audit details
- QMS renewal
- Interacting Successfully with Japanese Auditors
- Introduction
- Cultural principles
- Auditor mindset
- Business etiquette
- During an on-site audit
- Logistical issues for on-site audit
- Conclusion
- Appendices
- Appendix A: MHLW Ministerial Ordinance No. 169, 2004 (QMS Ordinance)
- Appendix B: PMDA Notification 0330001: Amendments to Ordinance and Notices for Drug and Medical Device Manufacturing Management and Quality Control (QMS/GMP) (Selected Articles)
- Appendix C: Selected FMA Application Forms
- Appendix D: Sample QMS On-Site Audit Schedule
- Appendix E: Statistics on PMDA Audits Conducted
- Appendix F: PMDA Audit Fees
Order now and we will ship you this report at no additional charge.
Price: $1500
Please contact us at researchstore@pacificbridgemedical.com if you have any questions.
