(GHTF Logo)
         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation

Study Group 1 (SG1) - Premarket Evaluation

Purpose of Study Group

SG1 has been charged with supporting the convergence of medical device regulatory systems through the development of harmonized guidelines on elements of a global regulatory model. These elements include definitions of key terms such as ‘medical device’ and ‘manufacturer’; essential principles of safety, performance, and labelling; principles of classification and conformity assessment; and recommendations for summary technical documentation.

In developing these guidelines, SG1 collaborates with other GHTF Study Groups in creating a global regulatory framework. It has additionally welcomed the contribution to its work of regulators and industry in other parts of the World.

Study Group Details

Documents

Updated 8 September 2008