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 ; 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ASEANCSDT 格式呈现。 CSDT 旨在协调医疗器械上市前注册提交的信息,并为...
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...
formally called the ASEAN Medical Device Directive (AMDD), that aimed to harmonize medical device regulations. The AMDD provides a more straightforward path to the market for medical device manufacturers. An important element of the AMDD is the ASEAN Common Submission Dossier Template (CSDT), a ...
The draft device registration requirements better align the Philippines with the ASEAN common submission dossier template (CSDT). The draft outlines the rule and risk based device classification system, with Class A (low risk — such as bandages) through Class D (high risk — such as...
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 ...