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Mattie718 replied to the topic Possibility of Global Regulation of Medical Devices? in the forum Introduction to Project Management 6 years, 7 months ago
While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bring new products to the market in the first place. Assuming there is one global regulatory body, it will essentially adopt all of the strictest rules possible from each country involved. The US would not join this effort if it would lead to loosened requirements for safety and efficacy, that would be going counter-productive. So, every country would have to agree on these rules which could lead to outrageous requirements for new products. Then everyone would be held to the same standard of excellence, even if some manufacturers would not be able to pay for the facility quality required of other country’s laws. Unfortunately, medical devices are not just judged on the finished product which you may find nice and pristine in a package. Regulatory bodies like the FDA care about the process used to make the product and even the quality of the suppliers which companies get their materials from. I just feel that each country has a vastly different perspective on how a medical device or drug should be manufactured and how that would affect its safety and efficacy.