Dossier Template (CSDT) •IncludeselementsoftheGHTFSummaryTechnical DocumentationforDemonstratingConformitytothe EssentialPrinciplesofSafetyandPerformanceof MedicalDevices(STED) •Intendedasaharmonisedformat
东盟通用提交档案模板 (CSDT; Common Submission Dossier Template) 是打算进入东南亚市场(ASEAN ; Association of Southeast Asian Nations) 的医疗器械制造商的通用模板。这份文件与申请表一起提交给监管机构(Regulatory Authorities)的设备信息应以ASEAN CSDT 格式呈现。 CSDT模板适用于一般医疗器械和体外诊断医疗器械;AMD...
common template for the submission of medical device information to medical device regulatory authorities of ASEAN member countries. Product registration applications for medical devices submitted to HSA must be prepared in the format set out in the ASEAN CSDT document. This guidance ...