Dossier Template (CSDT) •IncludeselementsoftheGHTFSummaryTechnical DocumentationforDemonstratingConformitytothe EssentialPrinciplesofSafetyandPerformanceof MedicalDevices(STED) •Intendedasaharmonisedformatforpre-market submissioninASEANmembereconomies •ProductRegistrationsubmissionstoHSAmustbe ...
ASEANCSDT在东南亚医疗器械指令 (AMDD; ASEAN Medical Device Directive) 的附件 4 中建议了ASEANCSDT 格式,该指令由东南亚地区的十 个国家:菲律宾、马来西亚、新加坡、泰国、文莱、越南、缅甸、老挝、柬埔寨、东帝汶签署。 东南亚通用提交档案模板 (CSDT; Common Submission Dossier Template) 是打算进入东南亚市场(ASEAN ...
ASEAN CSDT在东南亚医疗器械指令 (AMDD; ASEAN Medical Device Directive) 的附件 4 中建议了ASEAN CSDT 格式,该指令由东南亚地区的十 个国家:菲律宾、马来西亚、新加坡、泰国、文莱、越南、缅甸、老挝、柬埔寨、东帝汶签署。 东南亚通用提交档案模板 (CSDT; Common Submission Dossier Template) 是打算进入东南亚市场(ASE...
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 ...