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医疗器械是现代医疗必不可少的部分,其质量的好坏直接关系到医疗质量的好坏以及人民的身体健康。近年来美国及其他一些西方国家通过立法对医疗器械的生产与销售实施了管理,因而提高了医疗器械的质量。
Medical devices are an indispensable part of modern medicine. Their quality is directly related to the quality of medical care and the health of the people. In recent years, the United States and some other western countries have passed legislation to manage the production and sales of medical devices, thereby improving the quality of medical devices.