Regional Harmonization Initiatives

IMDRF seeks to maintain working relationships with regional organizations and other international entities that have a mutual interest in medical device regulatory activities which are directly related to the common goals of fostering global convergence, leveraging resources and making available safe and effective medical devices globally.

Such organizations may be invited to attend a Management Committee meeting as an observer.

Regional Harmonization Initiative Representatives

APEC LSIF Regulatory Harmonization Steering Committee

• Shu-Fen Wang
  Deputy Director
  Division of Medical Devices and Cosmetics
  Taiwan Food and Drug Administration
  Email: aa6056 [at] fda.gov.tw (aa6056[at]fda[dot]gov[dot]tw)
• Cheng-Ning Wu
  Section Chief
  Division of Medical Devices and Cosmetics
  Taiwan Food and Drug Administration
  Email: emilywu [at] fda.gov.tw (emilywu[at]fda[dot]gov[dot]tw)

Global Harmonization Working Party (GHWP)

• Dr Xu Jinghe
  GHWP Chair
  Deputy Commissioner
  National Medical Products Administration (NMPA)
  People's Republic of China
  Email: jhxu_nmpa [at] 163.com (jhxu_nmpa[at]163[dot]com)

Pan American Health Organization (PAHO)

• Maria Luz Pombo
  Unit Chief
  Quality and Regulation of Medicines and Health Technologies (QR) Unit
  Department of Innovation, Access to Medicines and Health Technologies (IMT)
  Email: pombomar [at] paho.org (pombomar[at]paho[dot]org)

• Nilda Enriquez
  Consultant
  Quality and Regulation of Medicines and Health Technologies (QR) Unit
  Department of Innovation, Access to Medicines and Health Technologies (IMT)
  Email: enriquezn [at] paho.org (enriquezn[at]paho[dot]org)

African Medical Devices Forum (AMDF)

• Paulyne Wairimu
  AMDF Chair
  Head of Medical Devices and Diagnostics Pharmacy and Poisons Board
  Kenya
  Email: pwairimu [at] pharmacyboardkenya.org (pwairimu[at]pharmacyboardkenya[dot]org)