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 > Study Groups > Study Group 2 (SG2) > SG2 Archived Documents |
Title |
Description |
Date Posted |
|---|---|---|
| SG2/N68R3: 2005 PDF Word |
Summary of Current Requirements for Where to Send Adverse Event Reports | 01 February 2006 |
| SG2(PD) / N87R7 PDF Word |
Medical Devices: Post Market Surveillance: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (Based on GHTF SG2 N32v5.2) | 31 March 2006 |
| SG2(PD) / N54R6 PDF Word |
Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices | 17 November 2005 |
| SG2(PD) / N57R6 PDF Word |
Medical Devices: Post Market Surveillance: Content of Field Safety Notices | 17 November 2005 |
| SG2(PD) / N79R5 PDF Word |
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form | 17 November 2005 |
| SG2/N61R4 PDF Word |
PMS Harmonization Chart | November 2004 |
| SG2/N31R8 |
Medical Device Postmarket Vigilance and Surveillance: Proposal for Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative | 22 December 2003 |
| SG2/N32R5 |
Medical Device Postmarket Vigilance and Surveillance: Universal Data Set for Manufacturer Adverse Event Reports | 22 December 2003 |
| SG2-N36R7 |
Manufacturer's Trend Reporting of Adverse Events | 28 March 2003 |
| SG2-N9R11 |
Global Medical Device Competent Authority Report [Contains link to fillable WORD version of form] |
28 March 2003 |
| SG2-N33R11 |
Medical Device Postmarket Vigilance and Surveillance: Timing of Adverse Event Reports | 28 March 2003 |
| SG2-N20R10 PDF Word |
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria | 12 July 2002 |
| SG2-N6R3 PDF Word |
Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan | *R2 re-posted, 25 October 2000 and replaced by the posting of R3 on 12 July 2002 |
| SG2-N21R8 |
Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative | Unknown *Reposted: 15 October 2000 |
Updated 23 December 2009
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