医疗器械出口加拿大注册准入.pdf

加拿大卫生部（Health Canada）为医疗器械设立两种证书： ① medical device licences (MDL) ② medical device establishment licences (MDEL) 一旦获得证书，产品便能够在加拿大经销。 Once a device receives the appropriate medical device licence, it can be distributed in Canada. MDEL适用于进口，经销I到IV类医疗器械的用户以及生产I类产品的制造商。 MDELs are issued to companies that import (Class I to IV), distribute (Class I to IV) or manufacture (Class I) medical devices. Step1:阅读官方指南 Step2:确定产品是否为医疗器械 M Step3:确定产品是否符合MDEL路径 D E Step4:申请小企业费用减免（国内国际都适用） L 7步申请 小企业定义 证 MDEL证书 ①少于100名员工 书 ②年总收入在3万到5百万加币之间(between $30,000 and $5 million CAD) Step5:填写申请表格 Step6:缴费/4590CAD Step7:提交申请（提交方式可选择发送邮件或者邮寄） *技术审评周期约为120天 MDL适用于II,III,IV类医疗器械。 MDLs are issued for Class II, III and IV medical devices. 像III,IV类这些高风险的医疗器械，申请者必须提供临床有效性证明，这些证明包括临床试验， 临床综述，变化分析和真实世界证明综述。 As Class III and IV medical devices pose the highest level of risk, applications for licensing must contain evidence of their clinical effectiveness. Such evidence includes clinical trials, clinical reviews, meta-analyses and real-world evidence reviews. (a)器械名称 (b)器械分类