Report of the APEC CoE Workshop: PMDA-ATC Medical Devices Workshop 2024
The PMDA held the “APEC Center of Excellence Workshop: PMDA-ATC Medical Devices Workshop 2024“, as an online event from October 29 to 30. This workshop was conducted as the Center of Excellence (CoE) which was designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC-RHSC). The workshop was provided for officials of overseas regulatory agencies involved in the review of medical devices and Quality Management System (QMS). A total of 37 regulators from Algeria, Australia, Bangladesh, Brunei Darussalam, Egypt, El Salvador, Ethiopia, Guyana, India, Myanmar, Nepal, Pakistan, the Philippines, Singapore, South Africa, Sri Lanka, Taiwan, Tanzania, Thailand, Timor-Leste, Uganda and Uzbekistan participated.
The webinar opened with the remarks by Dr. KONDO Emiko, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs.
On the first day of the workshop, lectures on the international harmonization of medical device regulations, as well as reviews of and QMS inspection for medical devices were provided. On the second day, a case study was presented on the post-market safety measures for medical devices, with participants divided into groups for discussion. Ten lecturers and facilitators were appointed from the PMDA.
(see the program for details[124KB])
This training was closed with the remark by Dr. KONDO Emiko, followed by Dr. FUKUDA Eriko, Senior Coordinator for International Training. 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:
”In general, the webinar is useful to know the area that we are not very aware of such as IMDRF terminology.”
”It is a great opportunity for us to learn developed regulatory system to apply this knowledge in the development of their own regulation. ”
”A wonderful opportunity. I got to learn a lot of things I can implement in my country.”