为医疗设备申请加拿大卫生部(Health Canada, HC)认证并确保产品符合相关法规,您需要遵循以下步骤: 1. 确定产品分类 首先,根据《加拿大医疗器械法规》(Medical Devices Regulations, MDR),确定您的医疗设备属于哪一类。加拿大的医疗器械分为I类、II类、III类和IV类,其中I类风险最低,IV类风险最高。 2. 准备技术文档...
二、监管机构 所有进入加拿大市场销售的医疗器械,均需要获得加拿大卫生部(Health Canada)的许可。 加拿大卫生部下属的医疗器械局(Medical Devices Directorate,MDD)是监督和评估加拿大诊断和治疗类医疗器械的安全性、有效性和质量的国家权威机构。 三、监管框架 主要基于以下两个法案: 食品药品法(Food and Drugs Act (R...
Medical devices have made health more mobile by allowing anyone to access medical services from their own home. Learn more about these sector changes here.
Thisguidancedocumentdoesnotcoverimportingmedicaldevicesforpersonaluseorforuseonanimals. Thisguidancedocumentexplains: medicaldevicesestablishmentlicensingundersections44to51.1ofthe?MedicalDevicesRegulations?(MDR)tothe?FoodandDrugsAct?(act) responsibilitiesofanypersonwhoimportsordistributesmedicaldevicesinCanada HealthCana...
(2001) Electromagnetic Interference in Medical Devices: Health Canada's Past and Current Perspectives and Activities. IEEE International Symposium on Electromagnetic Compatibility, 2, 1283-1288.Kok-Swang Tan, I. Hinberg, J. Wadhwani. . Electromagnetic interference in medical devices: Health Canada's ...
作者: Government of Canada, Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau 展开 摘要: Lists latest additions to the Medical Devices section of the Health Canada Web site 收藏 引用 批量引用 报错 分享 ...
proposal to make a number of changes to the drug and medical device regulations in an effort to modernise and streamline current requirements. Health Canada notes that the proposed targeted provisions and regulatory amendments to the Food and Drug Regulations and the Medical Devices Regulations would...
Health Canada Licensed We hold a Health Canada Establishment License All class II-IV medical devices that we sell are licensed by Health Canada and are covered by full warranty Fast shipping Add items to cart to see shipping options available for your address. Helpful Links Search Contact Us...
MDR conformity assessment services and fees > IVDR conformity assessment services and fees > Healthcare and Medical Devices courses and qualifications > Medical device technologies Download our medical device technology brochures. Active Medical Devices > Active Implantable Medical Devices > Devices utilizin...
Conkin Surgical designs specialty medical devices in Canada. Conkin developed the original uterine mobilizer, the Valtchev Uterine Mobilizer.