So you have one or more cleared medical devices in the US and now you want to license them in Canada. While the Canadian registration system seems simple, you can't just change the headers and submit “as-is” to Health Canada.
In this white paper, we will breakdown the differences between compiling an application for a Class III or IV non-IVD Canadian Medical Device License (MDL) and a 510(k) in a detailed, side-by-side comparison chart. We also discuss three potential show-stoppers:
We'll answer your biggest questions about the MDL application and more in this 17-page white paper.
Ken Pilgrim: Ken Pilgrim is a Director of RA/QA for Emergo and is located in Canada. With more than 20 years of experience in quality management, his expertise includes ISO 13485, CMDR implementation and audits, and medical device registration submissions in Canada, the EU, and US.
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
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