器械分类/文件名称 | Class II | Class III | Class IV |
行政信息 | 器械名称 | √ | √ | √ |
制造商信息 | √ | √ | √ |
监管通讯人信息 | √ | √ | √ |
发票信息 | √ | √ | √ |
医疗器械许可证申请费用表 | √ | √ | √ |
质量管理体系证书 | √ | √ | √ |
器械目的或预期用途 | √ | √ | √ |
Lincense申请类型(属于单一器械、系统(system)、测试盒、医疗器械组(group)、医疗器械家族(family)或医疗器械组家族(group family)?) | √ | √ | √ |
使用地点(家用,POC?) | √ | √ | √ |
含药信息(适用时) | √ | √ | √ |
是否释放辐射说明 | √ | × | × |
器械历史(之前是否已根据Medical Devices Regulations的Investigational Testing or Special Access规定在加拿大获得授权销售?) | √ | √ | √ |
识别器械是否含有 ≥ 0.1% w/w DEHP或由含有或衍生自双酚 A (BPA) 的原材料制成 | √ | √ | √ |
相互依赖器械的兼容性:预期与器械一起使用或运行的所有医疗器械的清单,包括其许可证号 | √ | √ | √ |
适用标准清单 | √ | √ | √ |
优先审核(如器械是用于严重、危及生命或严重衰弱的疾病或状况的关键的新的医疗器械) | × | √ | √ |
技术信息 | Executive Summary | × | √ | √ |
Table of Contents | × | √ | √ |
Background, which includes Device Description, Design Philosophy, and Marketing History | × | √ | √ |
Risk Assessment | × | × | √ |
Quality Plan | × | × | √ |
Summary of Safety and Effectiveness Studies, which includes List of Standards, Method of Sterilization, Summary of Studies, and Bibliography | × | √ | 见如下两行 |
Device Specific Detailed Information, which includes Material Specifications, Manufacturing Process Specifications, and List of Standards | × | × | √ |
Safety and Effectiveness Studies | × | × | √ |
Required information for any biological material (if applicable) | × | × | √ |
Near Patient Diagnostic Device Testing Results (if applicable) | × | √ | √ |
Labelling Material | √ | √ |
|
对于高水平消毒剂和灭菌剂和/或隐形眼镜消毒剂:必须提交安全性和有效性信息 | √ | × | × |