Japan Regulatory Requirements – PMDA Pre-submission Consultation Program

Get the most from the Japan PMDA Pre-Submission Consultation Program 

Medical device manufacturers entering the Japanese market often find it challenging to navigate the various regulatory mechanisms. For medical devices with improved and new technologies, the PMDA Pre-Submission Consultation Program is a valuable asset prior to device submission. The PMDA Pre-Submission Consultation Program is similar to the U.S. FDA Q-Sub Program, where the PMDA provides formal submission advice in writing.

 About the presenter 

Kenji Yashiro, manager,  Quality and Regulatory Affairs program, Emergo by UL 

Kenji Yashiro has more than 20 years of medical device regulatory knowledge, combined with extensive technical experience in device development, manufacturing and quality control. His background includes 40+ medical device registration submissions in Japan, pre-submission consultations with the PMDA, more than 10 years of experience with risk management files compliant with ISO 14971, more than 10 years of regulatory strategy research in Japan, and more than three years managing MAH responsibilities. 

Yashiro manages Emergo Japan’s Regulatory Affairs consulting team. In this role, he has peer-reviewed numerous regulatory filings and reports. Prior to Emergo, he held device development, manufacturing and quality control positions in the medical device industry as well as roles in regulatory affairs consulting.