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GHTF/SG2/N87:2012

XML Schema for Electronic Transfer of Adverse Event Data
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance

This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.

Source identity
Issuing body
GHTF/IMDRF
Reference
GHTF/SG2/N87:2012
Published (source metadata)
July 27, 2012
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XML Schema for Electronic Transfer of Adverse Event Data

XML schema specification for electronic transfer of adverse event data between regulatory authorities and manufacturers. Enables standardized vigilance reporting.