Activities of Harmonization By Doing; including development of pediatric medical devices

Abstract

Stakeholders of Regulatory agency, academia and industry in Japan and the United States initiated the dialogue to promote a global clinical trial for developing the innovative medical devices in 2003, so called "Harmonization By Doing (HBD)". The purpose of this activity is to discuss the challenges and their solutions for accommodating the local regulations in both countries by utilizing the concrete examples, "by Doing". The activities made a great contribution to facilitate a global device development and to eliminate "device lag". "Harmonization By Doing for children (HBD for children)" which focuses on the development of pediatric devices started as one of the activities of HBD in 2016. In the activity, stakeholders are discussing the concrete solutions for early applications and approvals of pediatric devices. In the session, I will introduce experiences of review of medical devices and share our achievements.