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GHTF (Global Harmonisation Task Force) study groups ask for feedback on latest documents:

This article was originally published in Clinica

Executive Summary

Three of the study groups within the Global Harmonisation Task Force have published on the GHTF website an updated list of the status of their proposed documents, which are being developed to encourage harmonised approaches throughout the world to addressing regulatory issues. Study Group 1 is inviting comments on both Principles of Medical Devices Classification and Principles of Conformity Assessment for Medical Devices by February 18, 2006. Study Group 2 is inviting comments by February 17, 2006 on proposed post market surveillance documents covering: Global Guidance for Adverse Event Reporting for Medical Devices; Content of Field Notices; and National Competent Authority Report Exchange Criteria and Report Form. Study Group 4, meanwhile, is asking for comments by February 1, 2006 on its Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy.

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