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Adverse Event Terminology

The purpose of this Work item is to:

  • to improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events, and
  • to establish IMDRF adverse event terminology composed of the following three parts: terms for medical device malfunction, terms for patient/user outcome and terms for part/component of medical device. (Note: Evaluation terms and code are out of the scope of this Working Group.)

Working Group Chair: Hiroshi Ishikawa, Japan contact Hiroshi Ishikawa

Working Group Membership: Regulator membership

PMDA

MHLW

  • Taku Oohara
  • Noriaki Tokunaga

US FDA

  • Nancy Pressly
  • Evan Jacobs

TGA

  • Pamela Carter
  • Jorge Garcia

Health Canada

  • Mary Raphael

ANVISA

  • Maria Gloria Vicente
  • Guilherme Antonio Marques Buss
  • Stela Candioto Melchior

WHO

  • Anita Sands

European Union

  • Jean-Fran├žois Roche (European Commission)
  • Claudius Griesinger (European Commission)
  • Fabio Faraulo (European Commission)
  • Tony Sant (MHRA- UK)

AHWP

  • WONG Woei Jiuang
  • SASIKALA Devi Thangavelu

Roszdravnadzor

  • Aysylu Valeeva
  • Elena Astapenko

Observer

  • Gulmira Mukhamedzhanova