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GHTF Study Group 2 - Post-market Surveillance/Vigilance

This page contains final documents produced by the GHTF Study Group 2. For a list of archived documents, see GHTF Archived Documents.

GHTF code Document title Date posted Pages
Technical documents
SG2 N87:2012 GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - DOC (72kb) GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - PDF (355kb) 27 July 2012 6
SG2 N87:2012 GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - XLS (18kb) 27 July 2012 N/A
GHTF/SG2/ N38R19:2009 GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - DOC (102kb) GHTF SG2 - National Competent Authority Report Exchange Program - July 2009 - PDF (59kb) 1 July 2009 9
GHTF/SG2/N79R11:2009 GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - DOC (208kb) GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb) 17 February 2009 13
GHTF/SG2/N54R8:2006 GHTF SG2 - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices - DOC (171kb) GHTF SG2 - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb) 30 November 2006 37
GHTF SG2/N57R8:2006 GHTF SG2 - Guidance - Content of Field Safety Notices - DOC (74kb) GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb) 27 June 2006 6
GHTF SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - DOC (75kb) GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb) 1 May 2005 10
GHTF SG2/N68R3:2005 GHTF SG2 - Where to Send Adverse Event Reports - DOC (68kb) GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb) 1 May 2005 5
GHTF/SG2/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2001 - DOC (65kb) GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb) 1 November 2004 7
GHTF/SG2/N31R8:2003 GHTF SG2 - Reporting Errors Medical Devices By Manufacturer - February 2003 - PDF (622kb) 1 February 2003 11
GHTF/SG2/N32R5:2002 GHTF SG2 - Universal Data Set for Manufacturer Adverse Event Reports - February 2003 - PDF (622kb) 1 February 2003 8
GHTF/SG2/N9R11:2003 GHTF SG2 - Global Medical Devices Competent Authority Report - January 2003 - PDF (249kb) 1 January 2003 6
GHTF/SG2/N36R7:2003 GHTF SG2 - Manufacturer's Trend Reporting of Adverse Events - January 2003 - PDF (488kb) 1 January 2003 9
GHTF/SG2/N33R11:2002 GHTF SG2 - Medical Device Postmarket Vigilance and Surveillance - Timing of Adverse Event Reports - 27 September 2002 - PDF (237kb) 27 September 2002 5
GHTF/SG2/N6R3:2002 GHTF SG2 - Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan - PDF (208kb) GHTF SG2 - Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan - DOC (180kb) 21 May 2002 34
GHTF/SG2/N20R10:2002 GHTF SG2 - Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria - DOC (68kb) GHTF SG2 - Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria - PDF (143kb) 21 May 2002 7
GHTF-SG2-N008R4 GHTF SG2 - Vigilance Reporting Guidance - June 1999 - DOC (75kb) GHTF SG2 - Vigilance Reporting Guidance - June 1999 - PDF (48kb) 29 June 1999 6
GHTF-SG2-N016R5 GHTF SG2 - Charge and Mission Statement - June 1999 - DOC (60kb) GHTF SG2 - Charge and Mission Statement - June 1999 - PDF (39kb) 29 June 1999 3
GHTF/FD: 99-7 GHTF SG2 - Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative - PDF - (52kb) 29 June 1999 11
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