Medical device single audit program (MDSAP)

Working Group Chair(s)
Kimberly Trautman
Food and Drug Administration (FDA)
United States of America
Membership
Regulator membership
Status
Work completed

Participants

Keith M Smith
Therapeutic Goods Administration (TGA)

Alba Maria Campos Pismel
Brazilian Health Regulatory Agency (ANVISA)
Patricia Serpa
Brazilian Health Regulatory Agency (ANVISA)
Vivian Cardoso de Morais
Brazilian Health Regulatory Agency (ANVISA)

Tian Shaolei
Chinese Food and Drug Administration (CFDA)
Wang Aijun
Chinese Food and Drug Administration (CFDA)
Zhu Ning
Chinese Food and Drug Administration (CFDA)

Rob Higgins
Medicines and Healthcare products Regulatory Agency (MHRA)

Ali Al-Dalaan
Asian Harmonization Working Party (AHWP)
Sabine Ohse
World Health Organization (WHO)

Hideyuki Kondo
Ministry of Health, Labour and Welfare (MHLW)
Kenichi Ishibashi
Pharmaceuticals and Medical Devices Agency (PMDA)
Yoichi Onodera
Pharmaceuticals and Medical Devices Agency (PMDA)

Kimberly Trautman
Food and Drug Administration (FDA)