Marketing in Canada: what is the difference between MDAL and MDEL?

MDAL and MDEL are the acronyms of Medical Device Application License and Medical Device Establishment License, respectively product license and establishment license. In particular, a manufacturer who intends to market medical devices in Canada must obtain a product license for class II, III and IV medical devices with the competent Authority Health Canada (according to the classification provided by the Canadian Regulation). An establishment license will not be necessary in this case, but it is required for Canadian distributors and importers. A foreign manufacturer must compulsorily obtain an establishment license (MDEL) if he intends to market class I medical devices directly in Canada , according to the classification provided by the Canadian Regulation.