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

What's New

Details of recent updates to the web site can be found in the table below.

If you have any questions about the content on the site, please email the GHTF Secretariat. If you experience any problems with the site, please contact the webmaster.

Date Status Page Details
2 February 2012 Added SG5 Proposed Documents Added "Clinical Performance Studies for In Vitro Diagnostic Medical Devices"
19 December 2011 Added Unauthorized Translation of GHTF Documents Added to Newsroom
19 December 2011 Added SG2 Proposed Documents Added "Definition and Classification of Field Corrective Actions, including Field Safety Corrective Actions, Recalls and Non Safety related Field Corrective Actions"
7 December 2011 Added SG2 Meeting Summaries Added minutes from 30 May-1 June 2011
23 November 2011 Added SG3 Meeting Summaries Added minutes from 13-15 April 2010
4 November 2011 Added Statement From the International Medical Device Regulators' Forum Added to Newsroom
21 October 2011 Updated Steering Committee Meeting Summaries Added 11-13 May 2011, Brisbane, Australia
5 October 2011 Added SG1 Proposed Documents Added "Principles of Conformity Assessment for Medical Devices" and "Principles of Medical Devices Classification"
22 September 2011 Added SG5 Proposed Documents Added "Clinical Evidence for IVD Medical Devices, "Key Definitions and Concepts" and "Scientific Validity Determination and Performance Evaluation"
22 September 2011 Added AHWG Final Documents Added "Unique Device Identification (UDI) System for Medical Devices"
22 September 2011 Added SG1 Final Documents Added "Label and Instructions for Use for Medical Devices"
22 September 2011 Updated SG1 Workplan Updated as of March 2011
22 September 2011 Added SG1 Meeting Summaries Added minutes from Feb 2011
7 July 2011 Added News Releases Added Transition of GHTF Chairmanship and Message from Outgoing Australian Chair
21 June 2011 Added Steering Committee Final Documents Added "Definition and Glossary of Terms Used in GHTF Documents"
10 June 2011 Added SG2 and SG5 Proposed Documents Added "Reportable Events During Pre-Market Clinical Investigations"
6 June 2011 Added SG2 Meeting Summaries Added minutes from 14-16 September 2010
20 May 2011 Added GHTF May 2011 Steering Committee Meeting - Outcome Statement Added to About GHTF
9 May 2011 Added SG3 Meeting Summaries Added minutes from 7-11 June 2010 and 16-20 October 2010
15 April 2011 Added AHWG Final Documents Added "Global Harmonization Task Force Medical Device Regulatory Model"
28 March 2011 Added Statement From the Chair - Update on Future Directions of GHTF Added to About GHTF
28 March 2011 Updated Steering Committee Meeting Summaries Added 2-4 November 2010 Meeting Minutes, Sydney, Australia
28 March 2011 Added SG1 Proposed Documents Added "Definition of the Term Medical Device" and "Essential Principles of Safety and Performance of Medical Devices"
28 March 2011 Added SG1 Final Documents Added "STED for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices"
1 March 2011 Added SG1 Meeting Summaries Added minutes from Oct 2010
1 February 2011 Added SG1 Meeting Summaries Added minutes from Mar, May, and Jun 2010
8 December 2010 Updated Steering Committee Final Documents Updated "GHTF Operating Procedures"
22 November 2010 Added AHWG Proposed Documents Added "Unique Device Identification (UDI) System
for Medical Devices"
19 November 2010 Added SG3 Final Documents Added "Quality Management System - Medical Devices - Guidance on corrective action and preventive action and related QMS processes"
19 November 2010 Added Position Statement: Single Global Nomenclature System for Medical Devices Added to About GHTF section.
19 November 2010 Updated Steering Committee Meeting Summaries Added 10-12 May 2010 Meeting Minutes, Vancouver, British Columbia, Canada
30 September 2010 Added SG4 Final Documents Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2, Part 4, and Part 5"
30 September 2010 Added SG1 Final Documents Added "Registration of Manufacturers and other Parties and Listing of Medical Devices"
24 Sept. 2010 Added SG2 Meeting Summaries Added minutes from Feb 2010
15 July 2010 Added SG1 Meeting Summaries Added minutes from Nov 2009
21 May 2010 Added SG1 Meeting Summaries Added minutes from Oct 2009 and Jan 2010
5 May 2010 Updated Steering Committee Meeting Summaries Added 10-12 November Meeting Minutes, Vancouver, British Columbia, Canada
26 April 2010 Added SG5 Final Documents Added "Clinical Investigations" and "Post Market Clinical Follow-Up Studies"
26 April 2010 Added Steering Committee Final Documents Added SC-N2R12 - GHTF Roles and Responsibilities
26 April 2010 Added SG1 Proposed Documents Added "Label and Instructions for Use for Medical Devices"
3 March 2010 Added SG2 Meeting Summaries Added minutes from 3-5 November 2009 - Kowloon Bay, Hong Kong
5 January 2010 Updated Meetings and Training Added APEC - Funded Medical Devices Regulatory Harmonization Delegation Visit to Canada and the United States
15 December 2009 Updated 2010 Meeting Calendar Changed to reflect new Steering Committee meeting date.
1 December 2009 Updated GHTF Steering Committee Membership List Updated membership list.
1 December 2009 Updated Steering Committee Meeting Minutes Added 10-12 May 2009 Meeting Minutes
1 December 2009 Added AHWG Proposed Documents Added "Unique Device Identification (UDI) System"
25 November 2009 Added SG4 Proposed Documents Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers" Part 5
25 November 2009 Added SG3 Proposed Documents Added "Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes"
25 November 2009 Added Steering Committee Final Documents Added SC-N2R11 - GHTF Roles and Responsibilities
4 November 2009 Added SG3 Meeting Summaries Added minutes from 10-12 May 2009 - Toronto, Canada
4 November 2009 Added SG2 Meeting Summaries Added minutes from 10-12 May 2009 - Toronto, Canada
3 November 2009 Added SG1 Meeting Summaries Added minutes from 10-12 May 2009 - Toronto, Canada
7 October 2009 Added SG4 Meeting Summaries Added minutes from 10-13 May 2009 - Toronto, Canada
16 September 2009 Added SG4 Proposed Documents Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers" Part 2 and Part 4
16 September 2009 Added SG2 Final Documents Added "Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program" - SG2/N38R19:2009
15 September 2009 Added SG3 Meeting Summaries Added minutes from 23-27 February 2009 - Tokyo, Japan
11 September 2009 Added SG1 Meeting Summaries Added minutes from several meetings
10 September 2009 Added GHTF Support of GMDN Agency's Board of Trustee Announcement Added Aug. 24th Memo: GHTF's statement regarding GMDN’s Board of Trustees announcement
17 July 2009 Added SG2 Final Documents Added "Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form" - SG2-N79R11:2009
10 July 2009 Updated Steering Committee Meeting Summaries Added 6-8 October Meeting Minutes, Ottowa, Ontario, Canada
7 July 2009 Added GHTF Documents Added Global Harmonization Task Force Medical Device Regulation Model (AHWG Draft)
7 July 2009 Added SG1 Final Documents Added "Definition of the Terms Manufacturer, Authorised Representative, Distributor and Importer"
7 July 2009 Added SG1 Proposed Documents Added "Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices"
16 June 2009 Updated GHTF Liaison Body List Updated list.
16 June 2009 Updated GHTF Steering Committee Membership List Updated membership list.
5 June 2009 Updated Conferences Added 5th APEC-Funded Seminar Slides
4 June 2009 Updated Conferences Added GHTF 12th Conference Slides
4 June 2009 Added SG2 Meeting Summaries Added minutes from 11-13 February 2009 - Brussels, Belgium
4 June 2009 Updated Directory of Study Group 2 Members Updated contact information for SG2 members
19 May 2009 Updated Conferences APEC - Funded Asian Medical Devices Regulatory Harmonization Delegation Visit to Australia
7 May 2009 Updated Conferences GHTF 12th Conference & 5th APEC Seminar Final Agendas
15 April 2009 Updated Directory of Study Group 2 Members Updated contact information for SG2 members
3 April 2009 Added SG3 Meeting Summaries Added minutes from 15-17 October 2008, Ottawa, Ontario, Canada and 16-19 June, 2008 - Canberra, Australia
19 March 2009 Updated Directory of IVD Subgroup Study Group 1 Members Updated information for SG1 IVD Subgroup members
3 March 2009 Added SG5 Proposed Documents Added "Post-Market Clinical Follow-Up Studies" - SG5(PD)N4R7
2 March 2009 Added SG1 Proposed Documents Added "Registration of Manufacturers and other Parties and Listing of Medical Devices" - SG1(WD)/N065
17 February 2009 Added SG2 Meeting Summaries Added minutes from 15-17 October 2008, Ottawa, Ontario, Canada
9 February 2009 Updated Conferences GHTF 12th Conference Registration Now Open
5 February 2009 Added SG3 Final Documents Added "Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers" - SG3/N17/2008
5 February 2009 Updated Directory of Study Group 1 Members Updated contact information for SG1 members
16 January 2009 Added GHTF Documents Added GHTF Retrospective Assessment documents
16 January 2009 Updated Directory of Study Group 2 Members Updated contact information for SG2 members
16 January 2009 Added SG2 Meeting Summaries Added minutes from 27-29 February 2008, Lisbon, Portugal
2 January 2009 Updated Directory of Study Group 1 Members Updated contact information for SG1 members

Updated 2 February 2012