1.2. In addition, this appendix calls for the development of an ongoing communication/consultation infrastructure between regulators and/or decision-making authorities and compliance assessment bodies for each party, so that regulators can determine and maintain the equivalence of their compliance assessment capabilities for medical devices and develop a cooperative approach to post-marketing surveillance. The first step would be an MRFE agreement between Trump and Trudeau, followed by the passage of MRFE legislation in the U.S. Congress and the Canadian Parliament. The business is not easy, but it has the potential to generate significant growth in business and economic activity for both countries. In the absence of agreement within the joint sector group on any of the above issues, the matter is referred to the joint committee in accordance with the framework agreement. Unless the parties have written agreements, commitments from mutual recognition agreements contained by one party with a country not party to this agreement have no effect or effect on the other party. 9.1 Ongoing monitoring of BMP compliance programs, which were assessed as equivalent at the end of the confidence phase, and all subsequent decisions regarding this equivalence must be made as part of a mutually developed and managed equivalency conservation program. This program is managed by the Joint Sector Group. The authorities responsible for the designation of compliance assessment bodies under this agreement are: there are, of course, areas in which regulators and companies would object that the other country`s inspection standards or practices are simply not good enough to be considered functionally equivalent. A mutual recognition agreement between Canada and the United States should contain a provision for a period, perhaps six months, during which regulators or regulated companies or individuals might object. These objections would be excluded from mutual recognition and would be on a list that would become an agenda for Kanakan and American CHCs.
Over time, the Commission could resolve these differences by encouraging either party to raise its standards or by encouraging both countries to adopt a better and mutually acceptable approach. If one of the two parties changes the rules, with the result that the government of the other country finds that they no longer meet the standard of functional equivalence, a mechanism would allow mutual recognition to be withdrawn.