The Pharmaceuticals and Medical Devices Agency (PMDA) is pleased to announce the holding of the "3rd PMDA Medical Devices Training Seminar" for international regulatory authorities scheduled for February 15-19, 2016. The PMDA Medical Devices Training Seminar is established for the exchange of medical device regulatory information between the PMDA and its counterpart agencies all over the world. The seminar is not open to the medical device industry or non-regulatory authorities. The seminar is not intended for Japanese government employees, either.
The 3rd PMDA Medical Devices Training Seminar is designed for officials who are engaged in the review of medical devices and in vitro diagnostics.
PMDA experts will present the following:
The training will be provided in English. All participants are expected to actively participate in all of the sessions.
Participation in the PMDA Medical Devices Training Seminar is limited to officials who are engaged in review of medical devices and in vitro diagnostics. Confirmation of registration and additional meeting information will be sent to the approved participants.
February 15 to 19, 2016, 10:00 a.m. to 5:30 p.m. (Day 4 start/end time may vary)
Day 1 (Monday, February 15, 2016)
10:00 - 10:15 | Welcome speech |
10:15 - 10:30 | Overview of Training Program/Schedule |
10:30 - 11:00 | Overview of PMDA (organization and functions) |
11:00 - 12:00 | Overview of Medical Device Regulations |
12:00 - 13:00 | Lunch Break |
13:00 - 15:00 | Review and Approval of Medical Devices (definition, classification, review process, scientific advices, etc) |
15:00 - 15:30 | Break |
15:30 - 16:00 | GCP/GLP inspections |
16:00 - 17:30 | Clinical Trials for Medical Devices |
Day 2 (Tuesday, February 16, 2016)
10:00 - 11:00 | Quality Management for Medical Devices |
11:00 - 12:00 | Post‐marketing Safety Measures for Medical Devices |
12:00 - 13:00 | Lunch Break |
13:00 - 14:00 | Utilization of International Standards |
14:00 - 15:00 | Third‐party Certification (by registered certification body) |
15:00 - 15:30 | Break |
15:30 - 17:30 | Introduction of Medical Device Regulations of Participant's Own Country (by participants) |
Day 3 (Wednesday, February 17, 2016)
10:00 - 12:00 | Industry-Government-Academia collaboration (discussion on strategic consultation, collaboration, etc with experts from academia and industry) |
12:00 - 13:00 | Lunch Break |
13:00 - 14:00 | Review and Approval of Medical Devices (combination products, etc) |
14:00 - 15:00 | Review and Approval of IVD |
15:00 - 15:30 | Break |
15:30 - 17:30 | Group work on Review of Medical Devices #1 |
Day 4 (Thursday, February 18, 2016)
10:00 - 17:30 | Site Tour (manufacturer’s training facility) |
Day 5 (Friday, February 19, 2016)
10:00 - 12:00 | Group work on Review of Medical Devices #2 |
12:00 - 13:00 | Lunch Break |
13:00 - 15:00 | International Activities on Medical Devices Regulation (IMDRF guidelines, etc) |
15:00 - 15:30 | Break |
15:30 - 16:00 | Wrap up |
16:00 - 16:30 | Closing remarks, Presentation of certificates |
Registration has closed on January 12, 2016.
There is no registration fee for this seminar.
Attendees are responsible for their own travel, accommodation and food expenses.
Pharmaceuticals and Medical Devices Agency (PMDA):
Shin-kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku,Tokyo 100-0013, Japan
Please use public transportation. Nearest Tokyo Metro Subway Stations:
For more information, please contact:
Secretariat, Medical Devices Training Seminar
E-mail: PMDA-MD-training@pmda.go.jp
Office of International Cooperation
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan