Clinical testing for these medical devices is shifting to the developed countries like China and India to cut down the clinical trial cost. One more reason for the clinical trial push to these developing countries is regulation for conducting clinical trial in these developing countries is almost nonexistent.
Due to the difference in the regulatory protocols, bringing the medical devices into the market of the other countries proved to be difficult. All the patients over the globe were not in accesses to the new medical devices. To bring down the complexity in clinical trial of the medical device, countries like Japan, Europe and US have agreed on a standard that, at minimum, met the regulatory requirements that already exist in their respective countries.
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