最新 - GHTF标准
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GHTF GHTF SG1 Principles of Medical Devices Classification - November 2012 - PDF (772kb)
GHTF SG1 Principles of Medical Devices Classification - November 2012 - PDF (772kb)[附网盘链接]是GHTF于不久前发布的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 GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - PDF (355kb)
GHTF SG2 - XML Schema for Electronic Transfer of Adverse Event Data - PDF (355kb)[附网盘链接]是GHTF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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IMDRF/GRRP WG/N63FINAL:2020 Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews - PDF (370kb)[附网盘链接]是IMDRF GRRP Working Group于25 September 2020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/Registry WG/N46 FINAL:2018 Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)
Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)[附网盘链接]是Patient Registries Working Group于27 March 2018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/N7FINAL:2013 UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)
UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)[附网盘链接]是IMDRF UDI Working Group于9 December 2013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/SaMD WG/N10FINAL:2013 Software as a Medical Device (SaMD) Key Definitions - PDF (119kb)
Software as a Medical Device (SaMD) Key Definitions - PDF (119kb)[附网盘链接]是IMDRF SaMD Working Group于9 December 2013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/SaMD WG/N41FINAL:2017 Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)
Software as a Medical Device (SaMD) Clinical Evaluation - PDF (1.10Mb)[附网盘链接]是Software as a Medical Device Working Group于21 September 2017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/RPS WG/N50FINAL:2018 Round 2, RPS Beta Testing Report - PDF (694kb)
Round 2, RPS Beta Testing Report - PDF (694kb)[附网盘链接]是Regulated Product Submission Working Group于27 July 2018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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Jeffrey Shuren, IMDRF Chair RPS Beta Testing Document - PDF (1.2Mb)
RPS Beta Testing Document - PDF (1.2Mb)[附网盘链接]是IMDRF RPS Working Group于16 May 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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(Edition 2) Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb)
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (621kb)[附网盘链接]是IMDRF MDSAP Working Group于24 March 2016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/MDSAP WG/N3FINAL:2013 Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)
Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition - PDF (244kb)[附网盘链接]是IMDRF MDSAP Working Group于9 December 2013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/Standards WG/N51 FINAL:2018 Optimizing Standards for Regulatory Use - PDF (769kb)
Optimizing Standards for Regulatory Use - PDF (769kb)[附网盘链接]是IMDRF Standards Working Group于5 November 2018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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(Edition 2) Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (734kb)
Medical Devices Post-Market Surveillance National Competent Authority Report Exchange Criteria and Report Form - PDF (734kb)[附网盘链接]是National Competent Authority Report Working Group于21 September 2017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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(Edition 4) IMDRF Terms of Reference - PDF (208kb)
IMDRF Terms of Reference - PDF (208kb)[附网盘链接]是IMDRF Management Committee于27 July 2018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/MC/N16FINAL:2014 IMDRF Document Format and Style Guide - PDF (75kb)
IMDRF Document Format and Style Guide - PDF (75kb)[附网盘链接]是IMDRF Management Committee于7 March 2014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。