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[Essential principles of safety and performance of medical devices and regulations of medical devices in China].

Consistent identification, selection and application of safety and performance principles to a medical device offers significant benefits to the manufacturer, user, patient or consumer, and to regulatory authority since it allows its manufacturer to design, manufacture and to demonstrate the device is suitable for its intended use. Moreover, eliminating differences between jurisdiction decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.