In the morning, after the brief overview of reviewing process and concept of generic medical devices in Japan, the actual case of PTA balloon catheter was studied with discussions in three groups. Two more cases, electrophysiology (EP) catheter and central monitor were studied as well, focusing on the differentiation between brand-new medical devices and generic medical devices, or how to evaluate the partial change for improvement.
In the afternoon, two cases, on surgical implanted electrical stimulator to the sacral nerves and interspinous process decompression system, were studied in view of the risk-benefit balance and the follow-up period for clinical trials and so on. As well as the session in the morning, there were active discussions among the participants.
At the end of the seminar, Dr. Tatsuya Kondo, Chief Executive of PMDA, gave closing remarks. He was delighted to learn that there had been very active discussions among all the participants, and wished this seminar to be a good opportunity to promote better mutual understanding for harmonized regulations for medical devices based on medical ethics.
After the closing remarks, the certificate of completing the seminar and the group photograph taken with PMDA executives were presented to each participant.
| Good opportunity to understand the general scheme of medical device regulations in Japan. Thanks to PMDA for the hard work to prepare the training seminar program.
Colleagues from Korea, Dr. Youngwoo Bae, Dr. Chang Hyung Lee and Dr. Seong In Baek (from left to right)