关键词: 医疗器械 标签 说明书 GHTF 指导原则GHTF Guidance on Label and Instruction for Use for Medical Devices LI Fei1,2 LIANG Wen1 FU Wei-wei3 YUAN Peng2 WEI Jing1 1 Liaoning Food and Drug Administration Technical Evaluation Center (Shenyang 110003) 2 China Food and Drug Administration (...
【中文版】GHTF Process Validation guidance工艺验证指南
The article reports on a guidance for classification of in-vitro diagnostics (IVD) for those who want to market internationally published by the Global Harmonization Task Force (GHTF). The guidance, which describes four categories...
关键词:临床评价 指导原则Interpretion of GHTF Medical Device Clinical Evaluation GuidanceWANG Ya-nan1 SHAN Xiao-hui2 CHI Ge2 1 Liaoning Medical Device Test Institute (Shenyang 110179) 2 Liaoning Centor for Drug and device Evaluation and Monitoring (Shenyang 110003)Abstract: Many new concepts and ...
a voluntary international group of representatives from medical device regulatory authorities and trade associations from Europe, the United States of America (USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities for use in the regulation...
Quality Management Systems – Process ValidationGuidanceüüAuthoring Group: SG3 3 Endorsed by: The Global Harmonization Task Force(GHTF)Date:Edition 2 - January ...
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance SG3 The Global Harmonization Task Force Edition 2 - January 2004 Authoring Group: Endorsed by: Date: Taisuke Hojo, GHTF Chair The document herein was produced by the Global ...
The Process Validation Guidance has been revised in sections 0 through 3.4, Figure 1 and Annex B. The revisions can be generalized in two categories: 1.) Editorial revision of terminology to be consistent with ISO 13485:2003 (i.e., “quality system” to “quality management system” and “...
指导原则进行部分解读,利于理解我国现行的医疗器械临床技术审查指导原则。 关键词:临床评价 指导原则 InterpretionofGHTFMedicalDeviceClinicalEvaluation Guidance WANGYa-nan SHANXiao.hui CHIGe 1LiaoningMedicalDeviceTestInstitute (Shenyang110179) 2LiaoningCentorforDruganddeviceEvaluationandMonitoring ...
2009 Page 2 of 25 Guidance on corrective action and preventive action and related QMS processes SG3(PD)/N18R8 70 Preface 71 The document herein was produced by the Global Harmonization Task Force, a voluntary group 72 of representatives from medical device regulatory agencies and the regulated in...