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Report of the PMDA-ATC Medical Devices Seminar 2018

PMDA-ATC Medical Devices Seminar 2018

Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (ATC) Medical Devices Seminar 2018 on November 12-16, 2018. This seminar was designed for medical devices and in-vitro diagnostic products reviewers from overseas regulatory authorities. Total of 25 regulators from 17 countries/regions (i.e. Argentina, Azerbaijan, Bangladesh, Brazil, Cameroon, Ecuador, Hong Kong, India, Indonesia, Malaysia, Philippines, South Africa, Sri Lanka, Taiwan, Tanzania, Thailand and Uganda) joined the seminar.

The seminar opened with remarks by Dr. Eriko Fukuda, Office Director, Office of International Cooperation and also Director of PMDA -ATC, followed by lectures and group works provided by over 20 PMDA staff members, a lecturer from Ministry of Health, Labour and Welfare and a lecturer dispatched from Japan Federation of Medical Devices Associations.
The topics discussed included medical device / in-vitro diagnostic product reviews, consultations, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Quality Management System (QMS), post-marketing safety measures, registration system, standards for medical devices (utilization of international standards, etc.), and third party certification process (see agenda for details).
Group works in case studies using examples of the new medical device review are also provided. In addition, key note speech by medical device industries and site visit to manufacturing facilities recommended by The Japan Federation of Medical Devices Associations were provided. The participants and PMDA staff members actively engaged in discussions throughout the seminar. On the final day of the seminar, the course completion certificates were handed to each participant by Dr. Kensuke Ishii.

Photos and participant comments


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Lectures were provided by experts of medical device / in-vitro diagnostic product reviews, GCP, GLP, QMS, registered certification bodies assessments and medical device developments. There were also presentations by representatives of every participating economy about their own systems of medical device reviews. Participants enthusiastically asked many questions.

Comments from the participants:
“Excellent training program. Workshop was very well designed and valuable, to all, who want to improve their understanding on regulation of medical devices.
All speakers are good and tried hard to explain and rectify the queries and off course succeeded.”
“Very useful presentation regarding the global medical device registries. The documents produced by the IMDRF would be definitely useful for making regulatory decisions.”
“The presentation was excellent. It explains well. Collaboration of PMDA, MHLW and their party like Registered Certification Bodies (RCBs) ensure the safety of medical devices that was launched in the market. Global auditing and monitoring the manufacturing of medical devices could improve the products.”


<Case studies>

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Group works in case study sessions are key sessions of the seminar. They provided opportunities where the participants discussed with other regulators as well as PMDA staff members on the important points to be kept in mind while conducting medical device reviews.
Comments from the participants:
“The session was very interactive and understandable as we practically participated in challenge of decision making on review and approval of the medical devices.”
 “The presentation is clear and knowledgeable. The group works help us to further understand the topic. PMDA has expertise on their assigned field. Training and standards are essential in the medical institution for risk reduction. “
“The presentation is clear and knowledgeable. The group works help us to further understand the topic. PMDA has expertise on their assigned field. Training and standards are essential in the medical institution for risk reduction.”


<Group photo>


Overall comments from the participants

“The seminar is very informative. It tackles most of the topics of medical devices. I learned a lot from the seminar. It gives me more idea. And I will recommend this seminar. Excellent. Thank you PMDA for allowing us to participate in this wonderful seminar.”
“Excellent, informative and insightful. Well organized, more topic discussed/ presented than I expected. Thank you very much for giving me the opportunity for joining the seminar.”
“PMDA-ATC MD seminar is very interesting. I’ve learnt a lot. Thank you PMDA Japan for giving us opportunity to attend this seminar. Overall the seminar is accommodated, well organized and the schedule is on time. It’s very nice to be able attend this seminar and thank you for your assistance and cooperation.”


PMDA-ATC Seminars are held periodically, with a different theme for each seminar.The Seminar announcements are posted on this website.
For any questions regarding PMDA Training Seminar, please contact us by clicking on the “Contact us” logo on top of the website, or please contact the Secretariat (e-mail: PMDA-ATC●pmda.go.jp).

Note: For the purpose of security, @ in the e-mail address is replaced with ●. Please replace ● with @ when you send an e-mail.

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