The United States is one of the country with the perfect medical devices regulation system, but China is on the way to reform its medical devices regulation system. The most important and urgent issue is, based on the present Chinese national situation, how to increase the administration level for the medical devices industry by using the experiences from the advanced country. This paper review and summarize the similarities and discrepancies on the medical devices regulation system between China and USA, and also provide some comments and suggestions for promoting the medical devices regulation in China.
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