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,...
【中文版】GHTF Process Validation guidance工艺验证指南
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 (...
Methods: By content translation and comparative study, the GHTF guidance "Label and Instruction for Use For Medical Devices"were studied. Results: GHTF guidance was introduced in detail by definition, general principles, label requirements and instruction for use requirements. Conclusions: China should ...
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 ...
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 “...
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...
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Au th orin g Grou p: En dorsed by: Date: SG3 The Global Harmonization Task Force Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the ...
ument is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, in- ...
document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part ...