中美医疗器械临床试验监管比较分析

The Comparison of the Regulations of Medical Device Clinical Trials between China and U. S.

临床试验是保证医疗器械有效性和安全性的重要途径之一。通过对比分析中美两国医疗器械临床试验监管法规,探讨了两国临床试验监管系统的差异,并提出意见和建议。

Clinical trials are essential for ensuring the safety and performance of medical devices, especially high - risk ones. This paper gives a detail comparison of the clinical trail regulations between China and U. S.. Through the analysis and comparison, we can see some problems about clinical trial regulation in China and propose some suggestions to improve the administration.