Report of the PMDA-ATC Medical Devices Webinar 2024
The PMDA held the “PMDA-ATC Medical Devices Webinar 2024” from October 31 to November 1. This webinar was intended for officials of overseas regulatory agencies involved in the review of medical devices and in vitro diagnostics (IVDs) and was attended by 27 regulators from Algeria, Australia, Bangladesh, Botswana, Brunei, Darussalam, Egypt, El Salvador, Ghana, Oman, Pakistan, Philippines, Saudi Arabia, Sierra Leone, Singapore, Sri Lanka, Taiwan, and Thailand.
The webinar opened with the remarks by Dr. KONDO Emiko, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, followed by Dr. FUKUDA Eriko, Senior Coordinator for International Training.
On the first day, lectures covered topics such as expedited review pathways, regulations of IVDs and IVD medical devices, as well as the reviews of software as a medical device and AI-based medical device. On the second day, a case study focused on the review of high-risk medical devices was presented, with participants divided into groups for intensive discussion. The PMDA staff members served as both lecturers and facilitators, receiving additional support from the lecturer representing Tohoku University Hospital.
(see the program for details[120KB])
This training was closed with the remark by Dr. KONDO Emiko. As a token of active participation in the webinar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:”The topics were presented clearly, and the examples used helped to understand the subject matter.”
”The part of case study and that one of PMDA team helps was really good to enhance the interaction.”
”More time may be needed to obtain more detailed information about the details of the approval process.”
"This training has allowed us to expand our knowledge on health regulation and has provided us with valuable tools in the regulation of medical devices and IVD.”