<4th Seminar Report> Overview of Rregulations on Medical Devices & Regenerative Medicine Products and Recent Topics in Japan.

On December 13th, we conducted 4th Academia Clinical Development Seminar at Multi Media Hall, Center of Medical Innovation and Translational research building. We welcomed Dr. Akihiro Watari from Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labor and Welfare. He gave his presentation at the Joint Symposium of Osaka University Hospital – Ramathibodi Hospital in Bangkok, Thailand on December 2nd and 3rd.
This lecture was addressed under the title of "Overview of regulations on Medical Devices & Regenerative Medicine Products and Recent Topics in Japan.", which had received many requests earlier.

The lecture was comprised of the following 4 topics : 1) The concept of review for medical devices, 2) The support system for creating innovative medical devices, 3) Cancer genomic medicine / Gene panel testing, and 4) The trend of medical devices utilizing AI, in the Ministry of Health, Labor and Welfare.

The lecture started with the explanation of the concept of basic review for the medical devices to get regulatory approval not only in Japan as well as in other than Japan. With showing many figures, Dr Watari spent some time talking about SAKIGAKE Designation System (先駆け審査指定制度) which is the unique designation scheme for drawing up product development efficiency and speeding up the approval review.
After that, as one of the ways to fight against cancer, he introduced the launching of the Cancer Genomics Promotion Consortium and the panel items of cancer-related gene that had been actually approved so far.
Then, he talked about how to deal with medical devices utilizing AI technology which have recently been a quite hot topic by using photographs from foreign cases and actual medical device diagnostics.

A number of review systems for getting regulatory approval in Japan have been established and well organized these days. Those systems include product evaluation indices for next-generation medical devices and regenerative medicine, SAKIGAKE Designation System, conditional early approval systems, and examination systems tailored to the characteristics of medical devices due to the revision of the Pharmaceutical Equipment Law. He placed special emphasis on following two matters which are gaining more significance: developmental support from macro viewpoint instead of micro, and cooperative device support by a team.

In recent years, it has become possible to select and develop the best program for medical devices individually, and that enables us to take the first step from "macro to micro",
Now we have come to the phase to discuss the most suitable regulatory science for medical devices is coming to the first stage. From the above, he concluded the lecture with the great expectations for the utilization of academia seeds.

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