Regulations are foreordain requirements for the development, promotion and approval of medical devices that assures it should be of good quality, safety and efficacy, in order to protect, improve and monitor the public health.After the development and before the distribution of medical devices into the market, it is supposed to be licensed by respective regulatory authorities across the globe.There is a giant-strides in the worldwide regulation of medical devices, as the manufacturers are forced to accomplish the regulatory requirements, documented standards, norms, guidelines, specifications, testing methods for the design, and manufacturing of devices.As proposed, various changes have to be implemented in the new EU MDR such as classification rules of medical device, technical document, registration of medical device, clinical investigations, post marketing surveillance and vigilance, conformity assessment, EUDAMED and so on.This work is an attempt to present the comparative study of regulations related to medical devices.The study will also explain the possibility of new regulatory regime to protect the rights of patients in the background of medical devices and technology.
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