Insights
Plain explanations of Health Canada, FDA and EU MDR requirements, written for quality and regulatory managers. Every article cites its primary sources.
Technical ArticleCanadaUnited States
Which FDA-cleared devices have no Canadian licence?
How we compare FDA 510(k) clearances with Health Canada's active licence listing to find devices cleared in the US but not licensed in Canada, and where the method stops.
GuideCanada
MDEL explained: who needs one and what Health Canada looks at
Who needs a Medical Device Establishment Licence in Canada, who is exempt, how it differs from a device licence, and what it takes to keep one active.
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