Transcription of GHTF SG2 Guidance for Adverse Event Reporting for Medical ...
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GHTF SG2 Guidance for Adverse Event Reporting for Medical ...
GHTF/SG2/N54R8:2006 FINAL DOCUMENT Global Harmonization Task Force Title: Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices Authoring Group: Study Group 2 Date: 30 November 2006 Georgette Lalis, GHTF Chair The document herein was produced by the Global Harmonization Task Force, which is comprised of representatives from Medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding Guidance for use in the regulation of Medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
Definition taken from IEC 60601-1-6:2004. See also Annex A for examples of potential abnormal use. Immediate adverse event report: For purposes of adverse event reporting, immediately means as soon as possible, but not later than 10 elapsed calendar days following the date of awareness of the event.
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