GHTF Medical Devices Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb)
标准简介
Medical Devices Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb)[附网盘链接]由The Global Harmonization Task Force于不久前发布，适用于全球范围。标准截图
![Medical Devices Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb)[附网盘链接]](/img/20210914103518b8nl3.jpg)
标准文档说明
标准文档类型为Medical Devices Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan - PDF (103Kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
IMDRF/NCAR WG/N30 FINAL: 2015
FINAL DOCUMENT
International Medical Device Regulators Forum
Title: Medical Devices: Post-Market Surveillance -IMDRF National Competent
Authority Report (NCAR) Pilot Plan
Authoring Group: National Competent Authority Report Working Group
Date: 2 October 2015
Toshiyoshi Tominaga, IMDRF Chair
This document was produced by the International Medical Device Regulators Forum. There are no restrictions
on the reproduction or use of this document; however, incorporation of this document, in part or in whole, into
another document, or its translation into languages other than English, does not convey or represent an
endorsement of any kind by the International Medical Device Regulators Forum.
Copyright © 2015 by the International Medical Device Regulators Forum
网盘链接
百度网盘：https://pan.baidu.com/s/1kykDord6Q26Q2Jb_vv-yfw
提取码：8ujp
【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。
加载用时：27.9583 毫秒
相关评论
相关文章
-
GHTF/SG1/N055: 2009 GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)
GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于March 26, 2009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。
-
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。
-
GHTF/SG3/N99-10:2004 (Edition 2) GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)
GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)[附网盘链接]是SG3于Edition 2 - January 2004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。
-
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。
-
IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Investigation - PDF (267kb)
Clinical Investigation - PDF (267kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019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。
-
GHTF/SG1/N055: 2009 GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)
GHTF SG1 - Definition Terms - Manufacturer - Authorised Representative - Distributor and Importer - PDF (41kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于March 26, 2009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。
-
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。
-
GHTF/SG3/N99-10:2004 (Edition 2) GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)
GHTF SG3 - QMS - Process Validation Guidance - January 2004 - PDF (162kb)[附网盘链接]是SG3于Edition 2 - January 2004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。
-
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。
-
IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Investigation - PDF (267kb)
Clinical Investigation - PDF (267kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019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。
-
GHTF/SG1/N071:2012 GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)
GHTF SG1 - Definition of Terms Medical Device and In Vitro Diagnostic Medical Device - May 2012 - PDF (240kb)[附网盘链接]是Study Group 1 of the Global Harmonization Task Force于May 16 , 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。
-
IMDRF MDCE WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Clinical Evidence - Key Definitions and Concepts - PDF (185kb)
Clinical Evidence - Key Definitions and Concepts - PDF (185kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019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。
-
IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)[附网盘链接]是IMDRF Good Regulatory Review Practices Group于31 October 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。
-
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。
-
GHTF/SG2/N57R8:2006 GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)
GHTF SG2 - Guidance - Content of Field Safety Notices - PDF (58kb)[附网盘链接]是Study Group 2于27 June 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。