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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 address premarket through 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 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