GHTF Study Group 1 - Pre-market Evaluation
This page contains final documents produced by the GHTF Study Group 1. For a list of archived documents, see GHTF Archived Documents.
Technical documents
GHTF code: GHTF/SG1/N78:2012 - Date posted: 2 November 2012
GHTF SG1 Principles of Conformity Assessment for Medical Devices - November 2012
GHTF code: GHTF/SG1/N77:2012 - Date posted: 2 November 2012
GHTF SG1 Principles of Medical Devices Classification - November 2012
GHTF code: SG1 N071:2012 - Date posted: 16 May 2012
GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012
GHTF code: GHTF/SG1/N065:2010 - Date posted: 27 August 2010
GHTF SG1 - Registration of Manufacturers and Listing of Medical Devices
GHTF code: GHTF/SG1/N055: 2009 - Date posted: 26 March 2009
GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer
GHTF code: N046:2008 - Date posted: 31 July 2008
GHTF SG1 - Principles of CA for IVD Medical Devices - July 2008
GHTF code: N044:2008 - Date posted: 5 March 2008
GHTF SG1 - Standards in Assessment of Medical Devices - March 2008
GHTF code: N055R6 - Date posted: 26 February 2008
GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008