Registration Review Guideline Of The Requirements For Submission Of Clinical Trial Data Of Medical Devices (November 25，2021)

一、前言 I Introduction 医疗器械临床试验数据是评价医疗器械安全有效性的重要支持性资料之一。规范地收集、整理、分析和递交医疗器械临床试验数据有助于提高临床试验实施和管理质量，同时有利于监管机构快速、高效地掌握临床试验的开展情况，提高审评效率。

Medical device clinical trial data is one of the important supportingdata for the evaluation of the safety and effectiveness of medical devices.Standardized collection, sorting, analysis and submission of medical deviceclinical trial data can help improve the quality in clinical trialimplementation and management, and also help regulatoryauthoritiestoquickly and efficiently grasp the situation of clinical trials andimprovetheefficiency of review.

为指导注册申请人规范递交临床试验数据及相关资料，以便更好地开展临床评价资料审评相关工作，制定本指导原则。The guideline is formulated to guide registration applicants tosubmit …