canada

Process Package — Marketing Authorization Canada (Health Canada) Complete framework for Health Canada MDL and MDEL. Covers Schedule 1 classification (16 medical device rules), MDL application by class, MDEL for importers/distributors, MDSAP certificate as mandatory QMS evidence, Annual Licence Review (April 1 deadline), bilingual EN/FR labeling, and faxed amendments. What’s included: SOP-REG-CA Marketing Authorization Canada…