PMDA held a webinar entitled “PMDA-ATC Medical Devices Webinar 2022 -Implementation and Adaptation of IMDRF documents in Japanese Medical Device Regulations-” November 28 to 30, 2022.
This webinar was intended for officials of overseas regulatory agencies involved in regulation of medical devices or IVDs. A total of 21 regulators from Bhutan, Cambodia, Chinese Taipei, Ethiopia, India, Malaysia, Myanmar, Pakistan, Philippines, South Africa, Tanzania, Thailand and the United States joined the webinar.
The participants were required to take the PMDA-ATC E-learning course “Medical Devices Review” prior to the webinar for preparatory study. The webinar opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC. The lecturers were given by the PMDA staff, lecturers were invited from the Ministry Health Labour and Welfare, the National Cancer Center Japan and the Tohoku University Hospital to add academic views.
On the 1st day of the webinar, lectures on regulations of IVDs and IVD medical devices, expedited review pathways, regulation for AI-based medical devices and development and practical application were given with subsequent Q&A sessions. On the 2nd and the 3rd day, the examples of the review of high-risk medical devices and the review of software as a medical device (SaMD) were given, respectively as case study materials, and the participants discussed intensively in four groups to derive their own opinions. < Program > see the attachment.
At the end of the webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA handed the course completion certificate to each participant virtually. Closing session was moderated by Dr. ISHII Kensuke, Senior coordinator of the webinar.
<Opening and Closing>
<Lecturers and Facilitators>
Comments from the participants:
“It was a good interactive session.”
“Very helpful and many topics covered today are new to me.”
“This provided me with updated knowledge on how PMDA evaluates SaMD.”
“Lecturers were very knowledgeable in answering my questions.”
“Case study examples are very good.”