中国药物评价2024，Vol.41Issue(2)：85-87,3.
医疗器械临床试验审批的监管考量
Regulatory Considerations for Clinical Trial Approval of Medical Devices
程茂波 1彭亮 1郭晓磊 1鞠珊 1穆兰兰 1张旭1
作者信息
- 1. 国家药品监督管理局医疗器械技术审评中心,北京 100081
- 折叠
摘要
Abstract
Objective:To conduct research and discussion on the optimization of the medical device clinical trial approval process and the focus of technical review requirements.Methods:By sorting out the relevant regulations,normative documents,clinical trial approval catalogs,and clinical trial review concerns,we have identified the basic principles and regulatory requirements for the technical review of medical device clinical trial approvals.Results:With the continuous improvement of the medical device clinical trial approval and super-vision system,the regulatory requirements have become more scientific and reasonable.Conclusion:The regulatory regulations for the approval of clinical trials of medical devices has been optimized,the procedures are more comprehensive,the technical review requirements are more scientific and reasonable,and the basic principles for the technical review of clinical trial approvals have been clarified,the review requirements have been unified,and the accessibility of high-risk Class Ⅲ medical devices to the human body has been promoted.关键词
医疗器械/临床试验/临床试验审批/技术审评/监管Key words
Medical devices/Clinical trial/Clinical trial approval/Technical review/Regulate分类
医药卫生引用本文复制引用
程茂波,彭亮,郭晓磊,鞠珊,穆兰兰,张旭..医疗器械临床试验审批的监管考量[J].中国药物评价,2024,41(2):85-87,3.
