Health Canada Medical Device Establishment License(MDEL)
加拿大医疗器械企业许可证（MDEL）
Class I medical device and in vitro diagnostic devicemanufacturers must secure a MedicalDevice Establishment License (MDEL) if selling directlyinto Canada and not through a distributor. However, if you sellthrough distributors in Canada, then your distributor must have anMDEL. Distributors and importers of medical devices and invitro diagnostic devices, regardless of the deviceclassifications, must secure a MDEL.
NOTE: Manufacturers of Class II, III and IV medical devicesand in vitro diagnostic devices do not require anMDEL.
I类医疗器械和体外诊断设备制造商如果不是通过分销商而是直接把设备销售到加拿大必须获得医疗器械企业许可证（MDEL）。如果是通过分销商销售到加拿大，那么你的分销商必须获得MDEL。医疗器械和体外诊断设备分销商和进口商，不管医疗设备的分类，必须获得MDEL。