APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2023
The PMDA held the “APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2023,” in an online workshop from November 14 to 16, 2023. This workshop served as the Center of Excellence (CoE) workshop for medical devices, designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC-RHSC). It catered to officials from overseas regulatory agencies involved in the review of medical devices and in vitro diagnostics (IVDs). The workshop saw participation from thirty regulators representing China, Chinese Taipei, India, Indonesia, Kazakhstan, Malaysia, Papua New Guinea, the Philippines, Slovenia, South Africa, Sri Lanka, Sudan, Tanzania, Uganda, and Zimbabwe.
The workshop 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 covering various aspects, including the international harmonization of medical device regulations, review of medical devices, quality management system (QMS) inspection for medical devices, and post-marketing safety measures for medical devices. On the subsequent days, case studies were provided on clinical evaluation and post-market safety measures for medical devices. Participants were divided into groups for discussions following each presentation. Engaging Q&A sessions followed every lecture. The workshop featured contributions from PMDA staff members and a professor from Tohoku University Hospital who served as lecturers and facilitators. (see the program for details)
This event was closed with the remark by Dr. UZU Shinobu. As a token of active participation in the workshop, the digital certification of Open Badge was given to the participants.
Photos and participant comments
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Comments from the participants:
“Learnings from this seminar will help the review of the registration of the medical devices and product recall”
“Very helpful as I am now in a better position to start the medical device unit”
“In general, the seminar is very good. The seminar is informative. The group discussion in the Case Studies help the participants to understand the lectures better.”
“Informative and interactive”
“The content was good”