In Japanese Pharmaceutical and Medical Devices Act Law (PMDAL), medical software was incorporated into the framework for medical device regulation (MDR) as Medical Device (MD) Program. The MD Program utilizing the "Dynamic" characteristics of software can be achieved from the proto type stage to the productization while maintaining the design and development concept for the improvement more easily than traditional popular MDs.

On the other hands, at the current situation surrounding MDs, the development and improvement of new concept MDs that take advantage of the "Dynamic" characteristics of software are also remarkable both in Japan and overseas. Taking the latest diagnostic MDs utilizing AI technologies as an example, the characteristics is far more "Dynamic" than traditional popular MDs. The trial MD reviewing systems under the PMDAL were introduced into legislation, and the revised PMDAL was promulgated in December of 2019. In the MDR under the revised PMDAL, the consideration of the "Dynamic" characteristics was also applied to legalization. I consider that the direction of MD reviewing should also follow the spirit of "Dynamic" included with the purpose of the revised PMDAL.

On this session, I would like to describe about the direction of "Dynamic" MD reviewing under Newly additional MDR including utilization of "MD Registries".