PMDA-ATC Medical Devices Seminar 2023
The PMDA held the “PMDA-ATC Medical Devices Seminar 2023” from December 5 to 7, 2023. This seminar was intended for officials of overseas regulatory agencies involved in the review of medical devices and in vitro diagnostics (IVDs) and was attended by 25 regulators from Bhutan, Indonesia, Malaysia, Pakistan, Papua New Guinea, the Philippines, Sri Lanka, and Thailand.
The seminar opened with the remarks by Dr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, followed by Dr. KUSAKABE Tetsuya, Senior Coordinator for International Training.
The first day featured lectures on the regulations of IVDs and IVD medical devices, expedited review pathways, development, and practical applications. At the roundtable discussion, representatives from each country gave presentations about the regulation for medical devices in their respective countries, and participants actively asked questions. On the second day, lectures on the regulation of AI-based medical devices, a regulatory approach for device software function, and a case study on the review of high-risk medical devices were provided. The third day included a case study on the review of software as a medical device, with participants divided into groups for intensive discussions. PMDA staff members served as both lecturers and facilitators, receiving additional support from lecturers representing the National Cancer Center Japan, Tohoku University Hospital, and Hiroshima University Hospital. (See the program for details)
This event was closed with the remark by Dr. UZU Shinobu. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
“Overall, it's very good experience for me. Nice meeting people from PMDA and other participants from other countries. Thank you for the very good seminar organization”
“All the sessions were very informative, interactive and engaging”
“The seminar was very good. The materials, lecturer and task for discussion”
“Very useful for review as well as policy making”
