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 (...
SG3(PD)/N18R81234567891011PROPOSEDDOCUMENT12GlobalHarmonizationTaskForce13141516Title:Qualitymanagementsystem–MedicalDevices–Guidanceoncorrectiveac-17tionandpreventiveactionandrelatedQMSprocesses1819AuthoringGroup:StudyGroup32021Date:22ndSeptember2009222324252627282930313233Guidanceoncorrectiveactionandpreventiveactionandrelated...
关键词:临床评价指导原则InterpretionofGHTFMedicalDeviceClinicalEvaluationGuidanceWANGYa-nanSHANXiao.huiCHIGe1LiaoningMedicalDeviceTestInstitute(Shenyang110179)2LiaoningCentorforDruganddeviceEvaluationandMonitoring(Shenyang110003)Abstract:ManynewconceptsandideasoftheNewrevisionoftheRegulationsandrelatedregistrationmeasuresof...
(USA), Canada, Japan and Australia. The document is intended to provide non-binding guidance to regulatory authorities 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 ...
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...
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 “...
The article reports on the publication by the Global Harmonization Task Force of a draft guidance for standards for unique device identifier (UDI) technology. According to the draft, it is important that a globally applicable UDI sys...
【中文版】GHTF Process Validation guidance工艺验证指南
The document is intended to provide non-binding guidance to regulatory authorities 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...
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 ...