1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
 |
About GHTF |  |
Steering Committee | |
Study Groups | |
GHTF Documents | |
Meetings & Training | |
Liaison Bodies | |
Newsroom |  |
| Title / Author | Format | Size | Date Posted |
| New
Australian Regulatory System for Medical Devices - Shelley Tang, Head, Device Registration and Assessment Section, Therapeutic Goods Administration |
265Kb | 7 June 2002 | |
| TGA’s
Medical Device Incident Report Investigation Scheme (IRIS) - Dr Jorge Garcia Manager, Medical Device Laboratory Program, TGA Laboratories |
367Kb | 7 June 2002 | |
| Significance
of standards in the regulations on medical devices in the US
and the EU - Klaus Stinshoff, Division of Medical Devices, Swissmedic - Swiss Agency for Therapeutic Products AND Steven Gutman, Director, Office of Device Evaluation, US Food and Drug Administration |
30Kb | 7 June 2002 | |
| Pharmaceutical
Affairs Law Revision - Soichiro Isobe, Deputy Director, Evaluation and Licensing Division, Ministry for Health, Labour and Welfare, Japan |
95Kb | 7 June 2002 | |
| Medical
Devices in Switzerland: Regulation and enforcement of regulatory
requirements by Swissmedic - Rainer Voelksen, Swissmedic |
28Kb | 7 June 2002 |
Asian Harmonization Working Party Information Session
| Title / Author | Format | Size | Date Posted |
| AHWP Survey Report | 348Kb | 12 June 2002 | |
| Report on AHWP Questionnaire Survey 2002 | 18Kb | 12 June 2002 | |
| Singapore
Regulatory Update - Wong Yew Sin |
59Kb | 12 June 2002 | |
| Korea
Regulatory Update - Lee Jeong Rim |
40Kb | 12 June 2002 | |
| Hong
Kong Regulatory Update - Constance Chan and Albert Poon |
26Kb | 12 June 2002 |
| Title/Author | Format | Size | Date Posted |
| Chinese
Regulatory Update - Hao Heping |
107Kb | 12 July 2002 |
Latin American Information Session
| Title / Author | Format | Size | Date Posted |
| PAHO - Antonio Hernandez |
328Kb | 12 June 2002 | |
| USA - Christine Nelson |
73Kb | 12 June 2002 | |
| Brazil - Wayne Brod Beskow |
381Kb | 12 June 2002 | |
| Chile - Nancy Fernandez Filo |
114Kb | 12 June 2002 | |
| Cuba - Dulce Ma. Martinez Pereira |
184Kb | 12 June 2002 | |
| Colombia - Nohra Rodriguez |
256Kb | 12 June 2002 | |
| Mexico - Adriana Velasquez |
992Kb | 12 June 2002 | |
| Panama - Eric Ulloa |
123Kb | 12 June 2002 | |
| Peru - Juan Villacorta |
109Kb | 12 June 2002 |
Workshop 1 - The Global Medical Devices Nomenclature (GMDN)
| Title / Author | Format | Size | Date Posted |
| GMDN
Historical Overview - Maurice Freeman |
143Kb | 18 June 2002 | |
| GMDN
MAPG - Maurice Freeman |
61Kb | 18 June 2002 |
Workshop 2 - Evaluation of Draft Guidelines for the Development of Medical Device Regulations
| Title / Author | Format | Size | Date Posted |
| Evaluation
of Draft Guidelines for the Development of Medical Device Regulations - Gerald Verollet, Department of Blood Safety and Clinical Technology (BCT), World Health Organization |
102Kb | 7 June 2002 | |
| A
Guide for the Development of Medical Device Regulations - Dr Michael Cheng, Temporary Advisor, World Health Organization |
115Kb | 7 June 2002 |
Workshop 3 - The Regulation and Supply of Refurbished Medical Devices
| Title / Author | Format | Size | Date Posted |
| Regulation
and Supply of Refurbished Medical Devices - FDA Perspective
- Lillian Gill, Senior Associate Director Center for Devices and Radiological Health, FDA |
122Kb | 7 June 2002 | |
| The
Regulation and Supply of Refurbished Medical Devices - Kevin Murray, MEDEC |
575Kb | 7 June 2002 | |
| The
Distribution and Refurbishment of Used Medical Devices - Masato Yoshida, JFMDA |
67Kb | 7 June 2002 | |
| Pre-Owned
Medical Equipment: Regulation & Markets - Jeffrey Gren, Director Office of Microelectronics, Medical Equipment & Instrumentation International Trade Administration U.S. Department of Commerce |
233Kb | 7 June 2002 | |
| Extracts
from Global Import Regulations for Pre-Owned (Used and Refurbished)
Medical Devices - Steven R. Harper, International Trade Specialist, Office of Microelectronics, Medical Equipment and Instrumentation, International Trade Administration/Trade Development, US Department of Commerce |
117Kb | 7 June 2002 | |
| Regulation
of Refurbished Devices - Mike Flood Conformity Assessment Branch Therapeutic Goods Administration Australia |
154Kb | 7 June 2002 | |
| Creating
Health Care Efficiencies Via Asset Management: The Pre-Owned
DI Equipment Example - GE Medical Systems |
238Kb | 7 June 2002 | |
| Refurbished
Medical Equipment - Peter Linders, COCIR |
31Kb | 7 June 2002 | |
| INVIMA - Nora Lucia Rodriguez |
201Kb | 18 June 2002 |
Plenary Session 1 - GHTF Business
| Title / Author | Format | Size | Date Posted |
| GHTF
Annual Report - Rita Maclachlan, GHTF Chair |
51Kb | 7 June 2002 | |
| GHTF
Strategic Directions - Brian Vale |
775Kb | 14 June 2002 | |
| SG1
Chair's Report - Maurice Freeman |
396Kb | 7 June 2002 | |
| SG2
Chair's Report - Kim Dix |
104Kb | 7 June 2002 | |
| SG3
Chair's Report - Victor Dorman-Smith |
749Kb | 7 June 2002 | |
| SG4
Chair's Report - Markus Zobrist |
52Kb | 7 June 2002 | |
| AHWP
Regional Update - Clarence Tan |
18Kb | 7 June 2002 | |
| Americas
Regional Update - Antonio Hernandez |
1185Kb | 7 June 2002 |
Plenary Session 2 - New and Emerging Technologies
| Title / Author | Format | Size | Date Posted |
| Keynote
Address - Catherine Livingstone |
41Kb | 21 June 2002 | |
| UK
MDA - David Jefferys |
38Kb | 21 June 2002 | |
| US
FDA - David Feigal |
1207Kb | 21 June 2002 | |
| Japan
Industry - Kenichi Matsumoto |
309Kb | 21 June 2002 | |
| Swissmedic - Rainer Voelksen |
26Kb | 21 June 2002 |
Plenary Session 3 - The Global Regulatory Model
| Title / Author | Format | Size | Date Posted |
| USA Industry - Michael Gropp |
Slides
1-20 (1232Kb) Slides 21-40 (1233Kb) Slides 41-60 (1363Kb) Slides 61-85 (1473Kb) |
11 June 2002 | |
| TGA
Australia - Rita Maclachlan |
773Kb | 11 June 2002 | |
| US
FDA - David Feigal |
85Kb | 11 June 2002 | |
| Health
Canada - Roland Rotter |
22Kb | 11 June 2002 | |
| MHLW
Japan - Soichiro Isobe |
26Kb | 11 June 2002 | |
| European
Commission - Joseph Putzeys |
16Kb | 12 July 2002 |
Plenary Session 4 - The Total Product Life Cycle: A Focus on Postmarket Surveillance and Vigilance
| Title / Author | Format | Size | Date Posted |
| TGA
Australia - Terry Slater |
25Kb | 12 June 2002 | |
| US
FDA - David Feigal |
75Kb | 12 June 2002 | |
| UK
MDA - David Jefferys |
70Kb | 12 June 2002 | |
| Europe
Industry - Roland Gerard |
92Kb | 12 June 2002 |
Updated 22 July 2004
|
GHTF Home | |
Site Map | |
Quick Links | |
Questions? | |
Site Feedback | |
Other Sites of Interest | |
Disclaimers | |