首页|现行医疗器械法规体系下医疗器械合规探讨——医疗器械临床评价

现行医疗器械法规体系下医疗器械合规探讨——医疗器械临床评价

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通过区分临床数据、临床证据、临床试验、临床评价的概念,引入法规要求,整理各类医疗器械产品在国内医疗器械注册/备案申报过程中临床评价的要求.其中,第一类医疗器械(含体外诊断试剂)不需进行临床评价,但要从实际使用和特点出发,判定其符合一类医疗器械要求.第二类和第三类(不含体外诊断试剂)有三种临床安全有效性评价路径,包括:①结合《免于临床评价医疗器械目录》进行对比分析法;②根据已上市医疗器械安全有效性证据进行评价法;③临床试验法.第二类和第三类体外诊断试剂应按照《体外诊断试剂临床试验技术指导原则》的要求进行临床试验.应按照法规要求形成医疗器械产品的临床评价资料.
Compliance Discussion Under the Current Medical Device Regulatory System—Medical Device Clinical Evaluation
By distinguishing the concepts of clinical data,clinical evidence,clinical trial and clinical evaluation,introducing regulatory requirements,sorting out the clinical evaluation requirements of various medical devices in the process of registration/domestic medical device filing.Among them,the first class medical devices(including in vitro diagnostic reagents)do not need clinical evaluation,but it needs to be determined that they meet the requirements of first class medical devices based on the actual use and characteristics of medical devices.There are three clinical safety and efficacy evaluation pathways for the second and third categories(excluding in vitro diagnostic reagents),including:① comparative analysis based on the"Catalogue of Medical Devices Exempted from Clinical Evaluation";② Evaluation method based on evidence of safety and effectiveness of medical devices already on the market;③ Clinical trial method.The second and third types of in vitro diagnostic reagents should undergo clinical trials in accordance with the requirements of the"Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents".Clinical evaluation data for medical device products should be formed in accordance with regulatory requirements.

medical devicesclinical trialsclinical evaluation

鲁文胜

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医诺睿康(北京)科技有限公司 (北京 100000)

医疗器械 临床试验 临床评价

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(19)