我国医疗器械注册管理制度存在的问题及建议

Problems and suggestions for registration management system of medical devices in China

详细介绍了1996年以来国内医疗器械注册管理制度在不同时期的发展,阐述了该制度在实践中遇到的第二类医疗器械注册审批尺度不一以及临床试验数据真实性、合规性不高等问题,指出了统一的科学理念对医疗器械审评审批支撑不够、临床试验需求得不到满足以及注册质量管理责任界定不清晰为问题产生的原因,提出了将医疗器械注册人制度确立为行业基本管理制度、理顺医疗器械相关审评审批制度的关系、扩大第二类医疗器械临床评价豁免范围以及加强医疗器械临床试验和注册人才的培养等建议。

The development of China’s medical device registration management system in different periods since 1996 was introduced in detail.The problems encountered in the practice of this system were described,such as the inconsistent scale of registration and approval of ClassⅡmedical devices and the lack of authenticity and compliance of clinical trial data,and the causes were pointed out including the insufficient support of medical devices review and approval from scientific ideas,unsatisfied clinical trial requirements and unclearly defined responsibility for registration quality management.Some suggestions were put forward such as establishing medical devices registrant system for fundamental industrial management,rationalizing the relationship between the review and approval systems of medical devices,expanding the scope of exemptions for clinical evaluation of ClassⅡmedical devices and strengthening the training of medical device clinical trials and registration personnel.[Chinese Medical Equipment Journal,2021,42(1):66-70]