基于风险的医疗器械临床试验伦理审查和质量管理

Ethical Review and Quality Management of Medical Devices Clinical Trials based on Risk

随着我国创新药品器械研发能力的不断提高,开展医疗器械临床试验的项目数量也在不断增多。医疗器械临床试验是验证器械安全性的重要环节,其结果的可靠性直接关系到器械上市后的安全,而临床试验的质量是临床试验的关键。通过对医疗器械临床试验各环节的质量风险因素进行规划、识别与评估,并探讨了降低风险的应对措施,建立完善医疗器械风险管理质量体系,实现临床试验全过程质量管理。

With the continuous improvement of the development capacity of innovative medical equipment in China,the number of projects to carry out clinical trials of medical devices is also increasing.Medical device clinical trial is an important link to verify the safety of the device,the reliability of the results is directly related to the safety of the device after marketing,and the quality of clinical trial is the key of clinical trials.Through planning,identifying and evaluating the quality risk factors in each link of the clinical trial of medical devices,this paper discussed the countermeasures to reduce the risk,to establish and improve the quality management system of the risk management of medical devices,and realize the quality management of the whole process of clinical trial.