Mr. Hiroshi Ishikawa

Pharmaceutical and Medical Device Agency (PMDA), Technical Expert, Division of Standards for Medical Devices, Office of Standards and Guidelines Development
Plenary: 
Plenary - Medical device regulation in Japan

Mr. Ishikawa, He belongs to Standards Dive of PMDA and responsible for creating or utilizing International Standards for Medical Devices. Currently, he is the member of Standards WG member and Chair of Adverse Event WG of IMDRF as a representative of PMDA.

Belonging: Technical Expert, Division of Standards for Medical Devices, Office of Standards and Guidelines Development, PMDA

Educational Background: Graduated Tohoku University Electrical Engineering,1972

Professional Experience:

  • 1972~2011 July Toshiba Cooperation (Medical Systems Div.)
  • 1998~2011 July GHTF SG2 WG member 2004~2011 July GHTF SC member
  • 2009 ~2011 July APEC LSIF RHSC committee member
  • 2009 ~ GMDN Agency PAG committee member
  • 2009~2013 UDI WG member 2011 Aug~ Division of Office of Review Management Pharmaceutical Affairs Consultation Group on R&D strategy, PMDA
  • 2015 March~ Division of Standards for Medical Devices, Office of Standards and Guidelines Development, PMDA
  • 2015 April~ IMDRF AE terminology WG Chair
  • 2016 ~ IMDRF Standards WG member
  • 2017 ~ IMDRF UDI implementation WG member Supporting IMDRF GRRP WG (EP, Labeling)