PMDA-ATC Medical Devices Seminar 2019 (Draft) Date

Review of Software (Categorization of Software as a “Medical Device” ... (Definition, classification, essential principle, review process, approval pr...

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PMDA-ATC Medical Devices Seminar 2019 (Draft) Date:November 25-29, 2019   Venue:PMDA Day 1, Nov. 25 (Mon) 9:30 - 9:45 Opening Ceremony 9:45 - 10:00 Seminar Outline

10:00 - 10:45 1. Outline of PMDA AM 10:45 - 11:45 2. International Harmonization (International Medical Device Regulators Forum (IMDRF), Asia Pacific Economic Cooperation-Life Science Innovation Forum-Regulatory Harmonization Steering Committee (APEC-LSIFRHSC), etc.) Lunch 11:45-13:00 13:00 - 14:00 3. Review and Approval of Medical Devices (Definition, classification, essential principle, review process, approval process, etc.) PM 1

14:00 - 15:30 4. Regulations, Legislative Systems and Current Effort for Medical Devices in Japan. (Approval system, certification system, early conditional approval system, sakigake system, etc.)

Break 15:30-15:45

PM 2

15:45 - 17:45 5. Introduction of Medical Device Regulations by Participants

18:15- Friendly Get Together

Day 2, Nov. 26 (Tue)

Day 3, Nov. 27 (Wed)

Day 4, Nov. 28 (Thu)

9:30 - 10:15 6. Consultation - from developing medical devices to getting marketing approval 9:30 - 10:30 13. Good Clinical Practice(GCP)/Good Laboratory Practice(GLP) Inspection and Inspection Based on 10:15 - 11:00 Standards of Reliability for Medical Devices 7. Review of Software (Categorization of Software as a “Medical Device” or not, etc.)

11:00 - 11:45 8. Review of Reprocessed Single-Use Device

10:30 - 11:45 14. Quality Management System (QMS) for Medical Devices/Outline of Medical Device Single Audit Program (MDSAP)

11:45-13:00

11:45-13:00

13:00-13:45 9. Standards for Medical Devices (Utilization of international standards, etc.)

13:45-14:30 10. Review Conducted by Registered Certification Bodies

14:30-15:00 15:00-15:45 11. Selection and Supervision of Registered Certification Bodies

15:45-16:30 12. Manufacturer's Expectation toward Third Party Certification System

Day 5, Nov. 29 (Fri)

9:30 - 11:45 18. Group Work on Review of Medical Devices 2 (Review cases where preparation of academic guidelines and/or training was required as conditions for approval, etc.)

11:45-13:00

9:00-18:00 17. Site Visit to Manufacturing Facilities 13:00 - 15:00 15. Group Work on Review of Medical Devices 1 (Review cases requiring discussion on clinical data, etc.)

13:00 - 15:00 19. Post-market Safety Measures for Medical Devices

15:00-15:30

15:00-15:30

15:30 - 17:30 16. Review and Approval of In Vitro Diagnostics (IVDs)

15:30 - 17:30 20. Development, Practical Application and International Deployment

17:30 - 18:00 Closing Ceremony