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Working Towards Harmonization in Medical Device Regulation |
| About GHTF | Steering Committee | Study Groups | GHTF Documents | Meetings & Training | Liaison Bodies | Newsroom |
| GHTF > Study Groups > Study Group 2 (SG2) > SG2 - Final Documents |
| Title | Description | Posted Date | Size | Comments To |
| SG2/N38R19 PDF Word |
Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program | 16 September 2009 | 9 pages | Isabelle Demade |
| Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form | 17 July 2009 | 13 pages | ||
| SG2-N54R8:2006 PDF Word |
Medical DevicesPost Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices | 18 December 2006 | 37 pages | Isabelle Demade |
| SG2-N57R8:2006 PDF Word |
Medical Devices Post Market Surveillance: Content of Field Safety Notices | 31 August 2006 | 6 pages | |
| SG2-N79R8:2006 PDF Word |
Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form | 31 August 2006 | 13 pages | |
| SG2/N47R4: 2005 PDF Word |
Review of Current Requirements on Postmarket Surveillance | 01 February 2006 | 10 pages | |
| SG2-N8R4 PDF Word |
Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices | 16 February 2000 *Reposted: 25 October 2000 |
6 pages, 47Kb-PDF 69Kb-Word |
|
| SG2-N16R5 PDF Word |
Charge & Mission Statement | 16 February 2000 *Reposted: 25 October 2000 |
3 pages, 40Kb-PDF 62Kb-Word |
*Reposted dates indicate when the document was reposted with a standard format cover sheet.
Updated 18 September 2009
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