最新 - GHTF标准
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IMDRF/Registry WG/N42FINAL:2017 Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)
Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)[附网盘链接]是IMDRF Patient Registries Working Group于16 March 2017发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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IMDRF/NCAR WG/N14 FINAL:2015 Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)
Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (195)[附网盘链接]是National Competent Authority Report Working Group于26 March 2015发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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IMDRF/NCAR WG/N31 FINAL: 2015 Medical Devices Post Market Surveillance National Competent Authority Report (NCAR) Pilot Plan; Implementing Material - PDF (562Kb)
Medical Devices Post Market Surveillance National Competent Authority Report (NCAR) Pilot Plan; Implementing Material - PDF (562Kb)[附网盘链接]是NCAR Working Group于2 October 2015发布的GHTF标准，适用于全球范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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IMDRF/AE WG/N44FINAL:2020 (Edition 3) Maintenance of IMDRF AE Terminologies - PDF (384kb)
Maintenance of IMDRF AE Terminologies - PDF (384kb)[附网盘链接]是IMDRF Adverse Event Terminology Working Group于18 March 2020发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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IMDRF/MC/N2FINAL:2021 (Edition 7) IMDRF Standard Operating Procedures - PDF (416kb)
IMDRF Standard Operating Procedures - PDF (416kb)[附网盘链接]是IMDRF Management Committee于25 March 2021发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG5/N7:2012 GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)
GHTF SG5 Scientific Validity Determination and Performance Evaluation - November 2012 - PDF (746kb)[附网盘链接]是Study Group 5 of the Global Harmonization Task Force于November 2 , 2012发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG5/N8:2012 GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)
GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)[附网盘链接]是Study Group 5 of the Global Harmonization Task Force于November 2 , 2012发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG5/N6:2012 GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)
GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)[附网盘链接]是Study Group 5 of the Global Harmonization Task Force于November 2 , 2012发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG4/N84:2010 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers - August 2012 - PDF (96kb)[附网盘链接]是Study Group 4 of the Global Harmonization Task Force于August 27, 2010发布的GHTF标准，适用于世界范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG4/N83:2010 GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010 - PDF (157kb)[附网盘链接]是Study Group 4 of the Global Harmonization Task Force于August 27, 2010发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG3/N15R8 GHTF SG3 - Risk Management Principles and Activities within a QMS - May 2005 - PDF (130kb)
GHTF SG3 - Risk Management Principles and Activities within a QMS - May 2005 - PDF (130kb)[附网盘链接]是GHTF Study Group 3于May 20, 2005发布的GHTF标准，适用于全球范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG3/N17:2008 GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)
GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接]是GHTF Study Group 3于December 11, 2008发布的GHTF标准，适用于全球范围。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG3/N18:2010 GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)
GHTF SG3 - Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - November 2010 - PDF (254kb)[附网盘链接]是Study Group 3于4 November 2010发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG2/N54R8:2006 GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)
GHTF SG2 - Medical Devices Post Market Surveillance Global Guidance for Adverse Event Reporting for Medical Devices - PDF (389kb)[附网盘链接]是Study Group 2于30 November 2006发布的GHTF标准，适用于全球。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
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GHTF/SG2/N79R11:2009 GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)
GHTF SG2 - Medical Devices Post Market Surveillance - February 2009 - PDF (142kb)[附网盘链接]是Study Group 2于February 17, 2009发布的GHTF标准，适用于世界。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。