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.

Some of these organizations are:

• APEC LSIF Regulatory Harmonization Steering Committee
• Global Harmonization Working Party (GHWP)
• Pan American Health Organization (PAHO)

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)

• Ali M. AL-DALAAN
  AHWP Chair
  Vice Executive President
  Medical Devices Sector
  Saudi Food and Drug Authority
  Email: AMDalaan [at] sfda.gov.sa (AMDalaan[at]sfda[dot]gov[dot]sa)

Pan American Health Organization (PAHO)

• Analía Porrás
  Chief
  Health Technologies Unit
  Medicines and Health Technologies Department
  Health Systems and Services
  Email: porrasan [at] paho.org (porrasan[at]paho[dot]org)
• Alexandre Lemgruber
  Regional Advisor
  Health Technologies Unit
  Medicines and Health Technologies Department
  Health Systems and Services
  Email: lemgruba [at] paho.org (lemgruba[at]paho[dot]org)