I read that there are regulations on medical devices regardless of where they are manufactured must be registered with the Food
Dana Dwirantwi
I read that there are regulations on medical devices regardless of where they are manufactured must be registered with the Food & Drug Administration. According to an article on the FDA, there are established classifications for if a device is 1,700 different generic types that then are grouped into 16 medical specialty panels. There are a number of factors that determine how medical devices get classified such as their intended use and the risk that the device poses to consumers.
Center for Devices and Radiological Health. (n.d.). Classify your medical device. U.S. Food and Drug Administration. Retrieved April 21, 2022, from https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
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