4. 申请加拿大医疗器械许可证（MDL）医疗器械许可证（Medical Device License, MDL）：Class II、III和IV的医疗影像设备需要申请MDL。提交申请：通过Health Canada的医疗器械管理系统（Medical Devices System, MDS）提交申请。需要提供详细的技术文档、质量管理体系证明、临床评价等。费用缴纳：在提交申请时，申请人还需要...
符合CMDR要求:加拿大医疗器械法规(CMDR,Canadian Medical Devices Regulations)规定了器械的合规义务,制造商需确保产品符合这些法规,涵盖设备的安全性、有效性以及上市后的监督要求。 通过以上步骤,制造商可以确保医用体温计符合Health Canada的市场准入要求,从而进入加拿大市场销售。
一、前期准备 了解法规要求: 详细研究加拿大卫生部(Health Canada)发布的医疗器械法规(Medical Device Regulations,MDR)和相关指南。 确定美容仪的风险等级(如Class I、II、III、IV),这通常基于产品的预期用途、设计特征、侵入性等因素。 准备技术文档: 产品描述:包括产品的名称、型号、结构、功能、工作原理等。 设计...
Step 4:Health Canada审核(具体MDEL申请流程见下); Step 5:30个工作日内解决发补问题,颁发证书,证书信息将公布在Health Canada官网上; Step 6:年度续证,截止时间为每年4月1日; ⛔️未及时递交年度续证,Health Canada将取消MDEL。 ⛔费用需在收到invoice后30天内支付,未及时支付MDEL年度续证费用,Health Ca...
Become Health Canada and FDA Compliant. We’ll help you meet regulatory requirements for NHPs, Medical Devices, Food, Drugs, cosmetics, etc.
Update: A permanent regulatory framework for COVID-19 medical devices (via amendments to the Medical Devices Regulations) came into force on February 22, 2023. Health Canada has instituted various approaches to facilitate the review and availability of health products which will help diagnose, ...
enthusiastic workshop of Health Canada Regulations with David Boudreau, Executive Director of Health Canada, who came by the Nordic TPO office to explain how their organization is working to facilitate the approval of medical devices, particularly as it applies to software as a medical device. ...
C. Rados, Medical device and radiological health regulations come of age. FDA Consumer magazine, 40: 1, 58-65 (2006).Carol Rados.Medical Device and Radiological Health Regulations Come of Age.. 2006Carol Rados.Medical Device and Radiological Health Regulations Come of Age. . 2006...
Health Canada Regulatory Services Services that help make the drug and health product regulatory process more manageable, predictable and successful. Regulatory Services Regulatory submissions and life cycle management of drug, medical device and other health products for Canada. ...
Medical Device Regulations Medtech Implementation of FDA’s Updated QMSR Jan 13, 2025 Image of Philips headquarters Cardiovascular Philips Faces a Different Kind of Recall in 2025 Jan 13, 2025 Graphic featuring the author's headshot (MD+DI Senior Editor Amanda Pedersen) and a pull-quote from th...