APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2022 - Explanation of/Insight into the IMDRF documents -
PMDA held a webinar entitled “PMDA-ATC Medical Devices Workshop 2022 - Explanation of/Insight into the IMDRF documents -” November 14 to 16, 2022.
This webinar was intended for officials of overseas regulatory agencies involved in regulation of medical devices or IVDs. A total of 26 regulators from Azerbaijan, Canada, China, Chinese Taipei, Ghana, Hong Kong, India, Indonesia, Malaysia, Pakistan, Peru, Philippines, Taiwan, Tanzania, Turkey, the United States, Uganda, and Zimbabwe 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. Opening session was moderated by Dr. ISHII Kensuke, Senior coordinator of the webinar. The lecturers were given by the PMDA staff and a lecturer was invited from the Tohoku University Hospital to add academic views.
On the 1st day of the webinar, lectures on international harmonization of medical device regulations, review of medical devices, QMS inspection for medical devices and post-marketing safety measures for medical devices were given with subsequent Q&A sessions. On the 2nd and the 3rd day, the examples of the clinical evaluation of medical device and the post-market safety measures for medical devices 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.
Photos and participant comments
<Opening & Closing>
<Lecturers>
<Participants>
Comments from the participants:
“Very good content and facilitators were well prepared and informative.”
“It was a wonderful webinar & I wish you give me a chance in future to learn about the Clinical Research of Drugs & Medical Devices.”
“I am happy to have this opportunity to re-enforce my learning at PMDA.”
“It is good to discuss between countries because we can build networking and know how the system works in different countries.”
“Everything was excellent, thank you PMDA for this valuable course.”