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         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation

SG 2 Proposed Documents

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SG2(PD) / N87R7
[ZIP]

The archive file "GHTF SG2 (PD) N87R7 guidance document bundle.ZIP" contains the working files which will form the basis of a pilot project conducted by the GHTF SG2 on electronic reporting. It also contains the GHTF SG2 guidance document relating to electronic reporting and a spreadsheet file which summarises the XML data structure being considered for this purpose.

GHTF is inviting public comments on GHTF SG2(PD) N87R7 and the associated data structure described in the spreadsheet. The public comments received will be considered alongside the results of the pilot project before the document progresses to "Final" status. For further information about the pilot the reader should contact the Study Group 2 Secretary or Chair.

29 August 2006 29 August 2007 Jorge Garcia

Updated 21 November 2007