最新 - GHTF标准
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GHTF Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)
Regulatory Authority Assessor Competence and Training Requirements - PDF (689kb)[附网盘链接]是GHTF于不久之前发布的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 Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb)
Points to consider in the use of the IMDRF Table of Content for Medical Device Submissions pre-RPS - PDF (153Kb)[附网盘链接]是GHTF于过去发布的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 Principles and Practices for Medical Device Cybersecurity - PDF (951kb)
Principles and Practices for Medical Device Cybersecurity - PDF (951kb)[附网盘链接]是The Global Harmonization Task Force于不久之前发布的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 Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) - PDF (2.04Mb)
Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) - PDF (2.04Mb)[附网盘链接]是The Global Harmonization Task Force于当前发布的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 In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (1.86Mb)
In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) - PDF (1.86Mb)[附网盘链接]是GHTF于不久之前发布的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 GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)
GHTF SG3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange - Novemeber 2012 - PDF (457kb)[附网盘链接]是The Global Harmonization Task Force于当前发布的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 GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)
GHTF SG1 - Standards in Assessment of Medical Devices - March 2008 - PDF (128kb)[附网盘链接]是The Global Harmonization Task Force于过去发布的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/N68R3: 2005 GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)
GHTF SG2 - Where to Send Adverse Event Reports - PDF (204kb)[附网盘链接]是GHTF Study Group 2于May 2005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/N61R4:2004 GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)
GHTF SG2 - PMS Harmonization Chart - November 2004 - PDF (51kb)[附网盘链接]是Study Group 2于November 2004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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SG1(PD)/N055R6 GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)
GHTF SG1 - Definition of the Terms of Manufacturer - 26 February 2008 - PDF (41kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于February 26, 2008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/SG2/N47R4:2005 GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)
GHTF SG2 - Review of Requirements on Postmarket Surveillance - PDF (187kb)[附网盘链接]是Study Group 2于May 2005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/SaMD WG/N12FINAL:2014 Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)
Software as a Medical Device Possible Framework for Risk Categorization and Corresponding Considerations - PDF (243kb)[附网盘链接]是IMDRF Software as a Medical Device (SaMD) Working Group于18 September 2014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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IMDRFIMDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)
MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)[附网盘链接]是IMDRF MDSAP Working Group于18 September 2014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 Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)
Glossary and Definition of Terms Used in GHTF Documents - PDF (163KB)[附网盘链接]是GHTF于之前发布的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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IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)
Unique Device Identification system (UDI system) Application Guide - PDF (3.53Mb)[附网盘链接]是IMDRFUDI WG于21 March 2019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。