Center for Medical Device Evaluation, Center for Medical Device Evaluation NMPA, Beijing, China.
Orthop Surg. 2019 Oct;11(5):715-719. doi: 10.1111/os.12498. Epub 2019 Sep 6.
Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data-analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.
III 类医疗器械是指那些植入人体内部、用于维持正常生命和保留原有组织或有机功能的医疗器械。由于这些设备与高风险相关，因此应严格监测和临床研究其有效性和安全性。这些医疗器械的临床研究旨在确保其有效性和安全性水平的可接受性。在设计临床试验时，研究者应确定评估医疗器械有效性和安全性的指标，选择合理的数据分析方法，并注意其他几个问题。虽然一些关于特定 III 类医疗器械的指南详细说明了这些方面，但仍没有全面的报告详细说明所有这些原则和方法。本文旨在总结指令原则中的共同特征，并为 III 类医疗器械的临床研究提供技术支持。
