SG2 - Final Documents

*Title*	*Description*	*Posted Date*	*Size*	*Comments To*
SG2-N54R8:2006 PDF Word	Medical DevicesPost Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices	18 December 2006	37 pages	Jorge Garcia
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/N68R3: 2005 PDF Word	Summary of Current Requirements for Where to Send Adverse Event Reports	01 February 2006	5 pages
SG2/N38R15 PDF Word	Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program	08 August 2005	9 pages
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	29 pages, 205Kb-PDF 142Kb-Word
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 21 November 2007