Transcript Speaker Bios

Mr. Kentaro Azuma,
MHLW, Japan
Mr. Kentaro Azuma is a Deputy Director in the Office of Medical Device Evaluation at the
Ministry of Health, Labour and Welfare (MHLW), Japan. He experienced several positions in
the field of pharmaceuticals and medical devices in the MHLW. Since he was appointed the
current position on July 2009, he is a member of the Global Harmonization Task Force
(GHTF) Steering Committee. He is also a member of the International Medical Device
Regulators Forum (IMDRF) Management Committee. He received his Master of Science
from the University of Tokyo and his MBA from Duke University.
Ms. ARIANTI ANAYA,
Indonesia
Arianti Anaya is currently the Director of Medical Device Production and Distribution Service,
Ministry of Health Republic of Indonesia.
She is responsible for managing the regulation of medical device and health household
product that are registered and distributed in Indonesia.
Prior to the position Director, Arianti (nickname: Ade) was the Head of Sub Directorate of
Medical Device Evaluation for Ministry of Health of Republic Indonesia, Directorate of
Medical Device Production and Distribution Service. As a regulator, she was actively
involved in the evaluation and implementation of the Medical Devices Regulations.
Throughout the 14 years experience in the medical device, IVD and health household
product sector Arianti has actively participated and became delegation in regional
harmonization activities including AWHP & ACCSQ-MDPWG.