11.02 Night Market

1
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.
2
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.