GHTF Study Groups

Global Harmonization Task Force (GHTF) Study Groups were established under the Procedural Document, “GHTF Roles and Responsibilities”. Generally the GHTF had five Study Groups that addressed premarket through to postmarket medical device issues.

To access archived documents regarding the GHTF Study Groups, see the GHTF Archived Documents page.

To access final documents regarding the GHTF Study Groups, see the GHTF final documents page.

  • Study Group 1 - Premarket Evaluation
  • Study Group 2 - Post-Market Surveillance/Vigilance
  • Study Group 3 - Quality Systems
  • Study Group 4 - Auditing
  • Study Group 5 - Clinical Safety/Performance

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

World Health Organization (WHO)

Swissmedic

 

Affiliate members

 

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Egypt - Egyptian Drug Authority  (EDA)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

South Africa - South African Health Products Regulatory Authority (SAHPRA)