我国医疗器械临床试验监管现状分析及对策探讨

Analysis of Current Status of Management on Clinical Test of Medical Devices and Discussion of the Countermeasures

医疗器械的临床试验是医疗器械管理中的重要组成部分。一方面,通过临床试验,医疗器械的安全性和有效性得到合理评估,为医疗器械上市提供科学依据。另一方面,临床试验耗时长,花费多,如果管理不当,有可能增加社会成本,给生产企业甚至消费者带来沉重的经济负担,进而影响医疗器械行业的发展。本文分析了我国医疗器械临床试验管理现状及存在的问题,并且提出了一些改革医疗器械临床试验监管的对策建议。

Clinical test of medical devices is a critical part in the management of medical devices.In one hand,clinical test is used to evaluate the safety and efficacy of medical devices and thus supply evidences for certification and furthermore for marketing of the products.In another hand,clinical test is time consuming and the cost could be high.A less efficient management could be an obstacle for the development of medical device industry with induction of high social cost and heavy economic burden to both manufacturers and consumers.This paper analyzed current status of management and exist problems,and countermeasures are discussed on medical test management and supervision.