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:
- Quality System
- License Type
We'll answer your biggest questions about the MDL application and more in this 17-page white paper.
About the Author:
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.