1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > 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
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