1992 -

Working Towards Harmonization in Medical Device Regulation

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Study Groups

Global Harmonization Task Force (GHTF) Study Groups are established under the Procedural Document, “Roles and Responsibilities”. Currently GHTF has five Study Groups that address premarket through postmarket medical device issues.

• 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

Updated 14 April 2008

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