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manolo replied to the topic Possibility of Global Regulation of Medical Devices? in the forum Introduction to Project Management 6 years, 2 months ago
I don’t see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well which I do not think will happen. Also, the level of comfort with devices and drugs are not the same globally. A great example would be the thalidomide fiasco.