GHTF Study Group 1 - Pre-market Evaluation documents
This page contains archived GHTF documents only. Not all documents generated by GHTF are featured in this archive. For a list of final GHTF documents, see the GHTF final documents page.
Technical documents
GHTF code: GHTF/SG1/N68:2012 - Date posted: 2 November 2012
GHTF SG1 - Essential Principles of Safety and Performance of Medical Devices - November 2012
GHTF code: SG1 N70:2011 - Date posted: 16 September 2011
GHTF SG1 - Label and Instructions for Use for Medical Devices - September 2011
GHTF code: N011:2008 - Date posted: 21 February 2008
GHTF SG1 - Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) - February 2008
GHTF code: GHTF/SG1/N063:2011 - Date posted: 17 March 2011
GHTF SG1 - Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices - March 2011
GHTF code: SG1(PD)/N71R04 - Date posted: 15 March 2011
GHTF SG1 - Definition of the Term Medical Device - March 2011
GHTF code: N045:2008 - Date posted: 19 February 2008
GHTF SG1 - Principles of IVD Medical Devices Classification - February 2008
GHTF code: SG1-(PD)-N011R20 - Date posted: 5 March 2007
GHTF SG1 - Essential Principles of Safety and Performance of Medical Devices (STED)-March 2007
GHTF code: SG1-(PD)-N045R12 - Date posted: 9 February 2007
GHTF SG1 - Principles of In Vitro Diagnostic (IVD) Medical Device Classification - February 2007
GHTF code: SG1-(PD)-N046R3 - Date posted: 9 February 2007
GHTF SG1 - Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices-February 2007
GHTF code: SG1(PD)/N044 - Date posted: 3 October 2006
GHTF SG1 - Role of Standards in the Assessment of Medical Devices (revised)
GHTF code: GHTF SG1/N15:2006 - Date posted: 27 June 2006
GHTF SG1 - Principles of Medical Devices Classification
GHTF code: GHTF SG1/N40:2006 - Date posted: 26 June 2006
GHTF SG1 - Principles of Conformity Assessment for Medical Devices
GHTF code: SG 1 PD N015 - Date posted: 15 September 2005
GHTF SG1 - Principles of Medical Devices Classification - September 2005
GHTF code: SG 1 PD N040 - Date posted: 15 September 2005
GHTF SG1 - Principles of Conformity Assessment for Medical Devices - September 2005
GHTF code: SG1 N43:2005 - Date posted: 3 June 2005
GHTF SG1 - Labelling of Medical Devices - June 2005
GHTF code: SG1 N29R16:2005 - Date posted: 20 May 2005
GHTF SG1 - Definition of the Term "Medical Device" - May 2005
GHTF code: SG1 N41R9:2005 - Date posted: 20 May 2005
GHTF SG1 - Principles of Safety and Performance of Medical Devices - May 2005
GHTF code: SG1/N015R22 - Date posted: 17 November 2003
GHTF SG1 - Principles of Medical Devices Classification - 17 November 2003
GHTF code: SG1/N011R17 - Date posted: 25 October 2002
GHTF SG1 - Summary Documentation Conformity to Safety and Performance of Medical Devices - 25 October 2002
GHTF code: SG1/N044R4 - Date posted: 5 October 2002
GHTF SG1 - Role of Standards in the Assessment of Medical Devices - InVitro Diagnostic Devices - 5 October 2002
GHTF code: GHTF-SG1-N012R10 - Date posted: 24 February 2000
Role of Standards in the Assessment of Medical Devices
GHTF code: GHTF-SG1-N009R6 - Date posted: 24 February 2000
Labelling For Medical Devices
Meeting dates and meeting minutes
Date: 7-10 February 2011, Location: London, United Kingdom, Doc code: N082
GHTF SG1 - Meeting Minutes - February 2011 London
Date: 5-8 October 2010, Location: Santa Rosa, USA, Doc code: N081
GHTF SG1 - Meeting Minutes - October 2010 Santa Rosa
Date: 7-10 June 2010, Location: Sydney, Australia, Doc code: N/A
GHTF SG1 - Meeting Minutes - June 2010 Sydney
Date: 18-21 May 2010, Location: Tokyo, Japan, Doc code: N080
GHTF SG1 - Meeting Minutes - May 2010 Tokyo
Date: 23-26 March 2010, Location: Washington, USA, Doc code: GHTF.SG1.IVD
GHTF SG1 - Meeting Minutes - March 2010 Washington
Date: 26-29 January 2010, Location: Sao Paulo, Brazil, Doc code: N079
GHTF SG1 - Meeting Minutes - January 2010 Sao Paulo
Date: 16-19 November 2009, Location: San Jose, USA, Doc code: GHTF.SG1.IVD
GHTF SG1 - Meeting Minutes - November 2009 San Jose
Date: 13-16 October 2009, Location: Brussels, Belgium, Doc code: N076
GHTF SG1 - Meeting Minutes - October 2009 Brussels
Date: 10-12 May 2009, Location: Toronto, Canada, Doc code: N075
GHTF SG1 - Meeting Minutes - May 2009 Toronto
Date: 20-23 January 2009, Location: Sydney, Australia, Doc code: N074
GHTF SG1 - Meeting Minutes - January 2009 Sydney
Date: 14-17 October 2008, Location: Ottawa, Canada, Doc code: N073
GHTF SG1 - Meeting Minutes - October 2008 Ottawa
Date: 8-11 July 2008, Location: Buenos Aires, Argentina, Doc code: N072
GHTF SG1 - Meeting Minutes - July 2008 Buenos Aires
Date: 6-8 February 2008, Location: Bonn, Germany, Doc code: N067
GHTF SG1 - Meeting Minutes - February 2008 Bonn
Date: 5 February 2008, Location: Bonn, Germany, Doc code: SG1 N068
GHTF SG1-SG3-SG4 - Meeting Minutes - February 2008 Bonn
Date: 30 September-2 October 2007, Location: Washington DC, USA, Doc code: SG1 N066
GHTF SG1 - Meeting Minutes - Washington
Date: 12 May 2007, Location: Los Angeles, USA, Doc code: SG1 N064
GHTF SG1 - Meeting Minutes - Los Angeles
Date: 7-9 February 2007, Location: Kyoto, Japan, Doc code: N062
GHTF SG1 - Meeting Minutes - February 2007 Kyoto
Date: 3-6 October 2006, Location: Ghent, Belgium, Doc code: N060
GHTF SG1 - Meeting Minutes - October 2006 Ghent
Date: 28-31 March 2006, Location: Sydney, Australia, Doc code: N058
GHTF SG1 - Meeting Minutes - March 2006 Sydney
Date: 16 September 2005, Location: Washington, USA, Doc code: N/A
GHTF SG1 - Globally Harmonized Premarket Oversight Presentation - September 2005 Washington
Date: 21-24 February 2005, Location: Morges, Switzerland, Doc code: N056
GHTF SG1 - Meeting Minutes - February 2005 Morges
Date: 5-6 October 2004, Location: Lisbon, Portugal, Doc code: N055
GHTF SG1 - Meeting Minutes - October 2004 Lisbon
Date: 18-19 February 2004, Location: Canberra, Australia, Doc code: N054S
GHTF SG1 - Meeting Minutes - February 2004 Canberra
Date: 8-10 September 2003, Location: London, United Kingdom, Doc code: N/A
GHTF SG1 - Meeting Minutes - September 2003 London
Date: 23-25 March 1999, Location: Brussels, Belgium, Doc code: N/A
GHTF SG1 - Meeting Minutes - March 1999 Brussels