Loisance Daniel
Bull Acad Natl Med. 2012 Jan;196(1):175-92.
Complex administrative procedures have gradually been established for the evaluation of implantable medical devices, resulting in improved patient safety. These procedures include in vitro testing, animal experimentation, clinical premarketing studies, and post-market surveillance. Further improvements are needed, however, including more independent experts and clinical studies, while ensuring that the approval process is neither to slow nor too hasty.
针对植入式医疗器械的评估，已逐步建立起复杂的行政程序，从而提高了患者安全性。这些程序包括体外测试、动物实验、临床上市前研究和上市后监测。然而，仍需进一步改进，包括增加更多独立专家和临床研究，同时确保审批过程既不过于缓慢也不过于仓促。
