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...
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ASEAN CSDT 格式呈现。 CSDT 旨在协调医疗器械上市前注册提交的信息,并...
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 ...
registration submission for general medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the CSDT and the format that this information is to be submitted in. 1.2. Background...
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...