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...
医疗器械分类:加拿大医疗器械根据其风险水平进行分类,分类结果将决定申请的路径和要求。医疗器械分类依据加拿大医疗器械法规(Medical Devices Regulations,MDR)中的规定。 技术文件和验证报告:制造商需要提供完整的技术文件,包括医疗器械的设计、制造过程、性能评估和质量控制等方面的信息。此外,还需要提供验证报告和实验室测试...
60601-1 Medical Electrical Equipment. Other testing and certification services - In addition to testing and certifying medical devices for Canada, TÜV SÜD Product Service can also provide compliance testing for medical devices for other relevant ...
Canadian authorities are seeking public input through 27 March on a 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 th...
Work smarter with the only platform designed by regulatory experts to manage your compliance process. Compliance Navigator is the only digital, multi-user platform currently available for managing the compliance process for medical device and in-vitro diagnostics products. ...
medical imagingoccupational doseradiation safetyshieldingX鈥恟ay regulations and room design methodology vary widely across Canada. The Canadian Organization of Medical Physicists (COMP) conducted a survey in 2016/2017 to provide a useful snapshot of existing variations in rules and methodologies for ...
3)Medical Device Licence Renewal and Fee for the Right to Sell Licensed Medical Devices(20191104) 4)Fees for Health Canada -202206075)SOR-98-282-Medical Device Regulations-20220725 加拿大医疗器械分类 Health Canada医疗器械分类情况如下: 一、 加拿大医疗器械的分类 ...
MEDICAL DEVICES NATURAL PRODUCT COSMETICS Rely on Q&R Canada as your trusted partner for Canadian Regulatory Compliance. Working with you as your regulatory partner, we can and will provide exceptional, personalized and expert service as an integral component in building and protecting your company’s...
Medical device regulatory consulting is a specialized service that assists manufacturers, developers, and stakeholders in navigating the complex landscape of regulations governing the design, production, and marketing of medical devices. The purpose of medical device regulatory advisor is to guide innovators...
BSI Medical Devices provide comprehensive regulatory and market access services so medical device manufacturers can stay compliant and sell into global markets.