Canada is a well-established but lucrative market for medical devices. It has one-fifth the population of Brazil, but spends nearly as much on healthcare every year. Interested in learning more about how to export your devices to Canada? This short video tells you how. Topics covered include Health Canada, classification of products in Canada, quality system requirements and ISO-Canadian Registrars, Canada's Medical Device License (MDL), Medical Device Establishment License (MDEL), and more.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多以下列出中国国家食品药品监督管理局(CFDA)对於医疗器械公司会造成重大影响的文件,不过所提供的文件都只限於中文版。
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