Even though Canada, USA and Mexico have created a North American trade block by signing the North American Free Trade Agreement (NAFTA), regulation of medical devices among these countries has not been fully harmonized so a separate registration of Medical and IVD devices is required in each country. 

Canada Health has adopted regulatory system that takes more after the European Medical Device Directives rather than the US FDA’s regulatory system of substantial equivalence. In Mexico, the regulatory authority initiated a reform in 2010 after realizing that most USA and Canadian regulatory requirements are already part of the COFPRIS regulatory system. Therefore, a relatively rapid and simple method for registration of either the US FDA or the CH approved products can be done.