医疗器械东南亚注册技术文件的关键要素主要有如下几条：
1. Executive summary 执行摘要
2. Essential principles and methods used to demonstrate conformity用于证明符合性的基本原则和方法
3. Medical Device description 医疗器械说明
4. Summary of design verification and validation Documents设计验证和确认文件摘要
5. Medical Device labeling 医疗器械标签
6. Risk analysis 风险分析
7. Manufacturer information – shall include details of manufacturing information 制造商信息——应包括制造信息的详细信息.
