Will the new regulation have a major effect on U.S. manufacturers who market products in Canada?
Yes. Any U.S. manufacturer who is selling to Canada now will find that the regulatory requirements are going to go up significantly. To sell in Canada, manufacturers will have to be using a quality system that is based on ISO 9000. FDA’s quality system regulation is based very much on ISO 9000, and if manufacturers are already following it they may have no problem. But if they aren’t, they will have some very tough economic decisions to face in terms of the cost of exporting a product to Canada. Also, U.S. manufacturers must choose Canadian distributors who can meet the new requirements. On the plus side, Canada is working to harmonize regulations with the European Union and with the United States. A number of projects are under way, such as a mutual recognition agreement that is being considered with the EU. Canada is also engaged in joint review with FDA for some high-risk devices. Somewhere down the road, if FDA reviews are recognized in Canada and vice versa, that’s going to make t
