Search results with tag "Global harmonization task force"
Table of Contents European Medical Device Regulation …
ww2.orielstat.comof the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
GHTF SG1 Definition of the Terms ‘Medical Device’ and ‘In ...
www.imdrf.orgThe objective of the Global Harmonization Task Force (GHTF) is to encourage convergence at the global level in the evolution of regulatory systems for medical devices in order to facilitate trade whilst preserving the right of participating members to address the protection of public health by those regulatory means considered the most suitable.
医療機器 QMS省令 ～指摘事項等 について
www.pref.kyoto.jpこれは 医療機器 に係る規制 について 、日本 がGHTF(Global Harmonization Task Force) 等に加入 することにより 国際調和 を 図る中、各国規制 とできる 限り整合 を図ることを 主眼 に置き、国 際的 な医療機器 の品質 に係る標準規格 である ISO13485を基に、
Regulatory requirements of Medical Devices in MENA countries
www.dgra.deAgainst this background the efforts of the Global Harmonization Task Force (GHTF) to harmonize the Medical Devices regulation, offer a valuable contribution to ease the regulatory interconnection and intercommunication between the individual countries and the international economic operators of the Medical Devices industry.
GHTF SG3 Quality Management System - Medical Devices ...
www.imdrf.orgGuidance on the control of products and services obtained from suppliers. GHTF/SG3/N17R9:2008 December 11, 2008 Page 3 of 21 Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group
GHTF SG2 Guidance for Adverse Event Reporting for …
www.imdrf.orgThe document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide non-binding guidance to regulatory authorities for use in
GHTF SG5 Key Definitions and Concepts - IMDRF
www.imdrf.orgClinical Evidence – Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 April 26, 2006 Page 3 of 8 Preface The document herein was produced by the Global Harmonization Task Force, a voluntary group
PROPOSED REVISED DOCUMENT - IMDRF
www.imdrf.orgThe document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory authorities 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.
GHTF SG1 - Label and Instructions for Use for …
www.imdrf.orgLabel and Instructions for Use for Medical Devices Study Group 1 Final Document GHTF/SG1/N70:2011 September 16th, 2011 Page 3 of 17 . Preface The document herein was produced by the Global Harmonization Task Force, a
GHTF SG1 Safety and Performance of Medical …
www.imdrf.orgEssential Principles of Safety and Performance of Medical Devices Study Group 1 Final Document GHTF/SG1/N68:2012 November 2nd, 2012 Page 4 of 24 Preface The document herein was produced by the Global Harmonization Task Force, a
GHTF SG1 - Summary Technical Documentation …
www.imdrf.orgGHTF/SG1/N063:2011 . FINAL DOCUMENT . Global Harmonization Task Force . Title: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In
Quality Management systems - Process Validation …
www.variation.comGHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force
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