关键词: 临床评价, 医疗器械, 临床数据, 临床试验, 临床证据, 技术审评

Abstract: Clinical evaluation is critical to the determination of whether the risk benefit of medical devices meets the criteria for marketing authorization. The clinical evidence generated from clinical evaluation can be used as supporting evidence for regulatory decision-making. The clinical evaluation of medical devices is a top priority for domestic and foreign regulatory authorities, medical device manufacturers and stakeholders. The Medical Device Clinical Evaluation Working Group was established by the International Medical Device Regulators Forum (IMDRF) Management Committee in March 2018. It is a working group led by the Center of Medical Device Evaluation of the National Medical Products Administration. This working group drafted clinical evaluation-related documents after 18 months of research and discussion, which were approved and released by the IMDRF Management Committee in September 2019. The contents and main ideas of the three documents are summarized in this article. The progress in the clinical evaluation of medical devices in China and the implications of the three documents for clinical evaluation in China are discussed, and the challenges facing clinical evaluation in China are mentioned. This article is intended to provide reference for future research on clinical evaluation methods that are practical in China.

Key words: clinical evaluation, medical devices, clinical data, clinical investigation, clinical evidence, technical review