1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
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 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
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