2nd PMDA Medical Devices Training Seminar(DAY 2)

Topic 1: Introduction of Medical Device Regulations in Participant's country

Day 2 sessions started with the participants' presentations on the medical device regulations in his/her own country. Mr. Jack Liang from TGA and Ms. Gina Cardoso from ANVISA introduced the Australian and Brazilian system respectively in the morning, while Ms. Wei Xuan Tee and Ms. Amritamayee Sahoo from HSA and Ms. Szu-Yu Lee from Taiwan FDA presented on Singapore and Taiwan, respectively, in the afternoon. The medical device regulations in the U.S.A. was also presented by Mr. Andrew Durfor from US FDA, who is currently working at PMDA under the Mansfield Fellowship program. Through the exchange of information and Q&A, participants were able to understand the similarities and differences among those regulations.

 

Topic 2: Today's lectures

In between the introduction of each country's regulations, Mr. Nobuo Uemura from MHLW gave a special presentation on Health and Medical Services in Japan at the end of the morning session, based on his research performed during his time with PMDA. This lecture was a good overview of the national medical system including the Japanese health insurance system.

 

Topic 3: Case study

In the last session of the day, Ms. Sara Takahashi and Dr. Yoshimasa Yokoyama of Office of Medical Devices I presented the cases of brand new devices review, taking examples of a composite stent system for cerebral vascular and a left ventricular assist device (LVAD). The participants were divided into two groups and had active discussions on how to handle these cases and drew their own conclusions. It was a good exercise to consider the balance of risk and benefit from various aspects.

 

Comments from participant