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Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > 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 Secretary. If you experience any problems with the site, please contact the webmaster.
| Date | Status | Page | Details |
|---|---|---|---|
| 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 |
| 4 December 2008 | Updated | Steering Committee Meeting Summaries | Added 3-5 March Meeting Minutes, Kuala Lumpur, Malaysia |
| 1 December 2008 | Updated | Conferences | Added details and flyer for 12 GHTF Conference, 12-14 May 2009, Toronto, Ontario, Canada |
| 24 October 2008 | Added | SG4 Final Documents | Added "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements" |
| 8 September 2008 | Added | SG1 Final Documents | Added "Note: Discrepancy Between GHTF/SG1/ N040:2006 and GHTF/SG1/ N011:2008" |
| 4 September 2008 | Updated | SG3 Work Plan | Updated work plan. |
| 4 September 2008 | Updated | GHTF Calendar of Events | Added SG3 meetings. |
| 4 September 2008 | Added | SG3 Meeting Minutes | Added minutes from 6-8 February 2008 Meeting, Bonn, Germany |
| 26 August 2008 | Added | SG1 Final Documents | Added "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices" |
| 30 July 2008 | Added | SG5 Meeting Minutes | Added minutes from 19-21 May 2008 Meeting, Tokyo, Japan |
| 16 July 2008 | Modified | SG1 Proposed Documents | Moved "Principles of In Vitro Diagnostic (IVD) Medical Devices Classification" from Proposed to Archived |
| 10 July 2008 | Removed | SG1 Final Documents | Temporarily Removed "Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices" Pending Further Clarification of Wording Issue in Document |
| 9 July 2008 | Updated | GHTF Calendar of Events | Changed GHTF SC October 08 Meeting to 6-8 October 2008. |
| 3 July 2008 | Modified | Meetings | GHTF/APEC Training with PAHO (Pan American Health Organization) and LAHWP (Latin American Harmonization Working Party) rescheduled to 2009, location to be determined |
| 2 July 2008 | Updated | GHTF Steering Committee Membership List | Updated membership list. |
| 2 July 2008 | Updated | SG4 Directory of Study Group Members | Updated membership list. |
| 30 June 2008 | Added | 4TH Asia-Pacific Economic Cooperation (APEC)-Funded Seminar on Harmonization of Medical Device Regulations, - Presentation Slides | Added slide presentations. |
| 23 June 2008 | Added | SG1 Final Documents | Added SG1-N45 - Principles of In Vitro Diagnostic ( IVD) Medical Devices Classification |
| 23 June 2008 | Added | SG1 Final Documents | Added SG1-N46 - Principles of Conformity Assessment for In Vitro Diagnostic ( IVD) Medical Devices |
| 18 June 2008 | Added | SG1 Proposed Documents | Added SG1(PD)/N055R6 - Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer |
| 29 May 2008 | Added | SG1 Final Documents | Added SG1-N11 - Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) |
| 30 April 2008 | Updated | GHTF Calendar of Events | Added SG4 meetings - 14-17 October 2008 in Ottawa, Canada and 10-15 May 2009 in Toronto, Canada. |
| 30 April 2008 | Added | SG4 Meeting Minutes | Added minutes from 30 September - 2 October 2007 Meeting, Washington, DC, USA and 1-3 April 2008 Meeting in Paris, France |
| 25 April 2008 | Added | SG3 Proposed Documents | Added SG3(PD)N17R7 - Quality management system – Medical devices - Guidance on the control of products and services obtained from suppliers. |
| 16 April 2008 | Added | SG1 Final Documents | Added SG1-N44 - Role of Standards in the Assessment of Medical Devices |
| 14 April 2008 | Added | Steering Committee Final Documents | Added SC-N2R10 - GHTF Roles and Responsibilities and SC-N3R10 - GHTF Operating Procedures |
| 03 April 2008 | Updated | SG1 IVD Subgroup Participants | Added new members. |
| 14 March 2008 | Added | SG5 Proposed Documents | Added SG5(PD)/N3R7 |
| 14 March 2008 | Updated | GHTF Steering Committee Membership List | Updated contact information. Added new member. |
| 14 March 2008 | Updated | Steering Committee Meeting Summaries | Added 30 September - 2 October 2008 Meeting Minutes |
| 13 March 2008 | Updated | 2008-2009 Calendar of Events | Updated Calendar for 2008-2009 Meetings |
| 13 March 2008 | Added | GHTF/APEC Training on 8-10 Oct 2008 in Mexico with PAHO (Pan American Health Organization) and LAHWP (Latin American Harmonization Working Party) |
Added announcement of upcoming training event |
| 12 March 2008 | Added | SG2 - Minutes from 30 September - 2 October 2007 Meeting, Washington, DC | Added meeting minutes |
| 21 February 2008 | Updated | SG2 Directory of Study Group Members | Updated Membership List |
| 21 February 2008 | Updated | SG2 Meeting Summaries | Added minutes from September 2005, March 2006, June 2006, and January-February 2007 meetings |
| 14 January 2008 | Updated | GHTF/APEC Training - 5-7 March 2008 - Kuala Lumpur, Malaysia | Added Announcement, Agenda and Registration information in PDF format. |
| 10 January 2008 | Updated | SG4 Directory of Study Group Members | Updated Membership List |
Updated 15 July 2010
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