我国医疗器械和康复辅具的监管现状与分析

目的 分析医疗器械和康复辅具的特性和关系,为我国康复辅具管理属性的决策提供参考.方法 对医疗器械和康复辅具的定义、分类、标准、监督管理等方面进行对比分析.结果与结论 目前我国康复辅具还不适宜从整体上纳入医疗器械管理范畴,符合医疗器械定义、预期以医疗为目的且属于国家食品药品监督管理局监管职能的产品,可纳入医疗器械管理.

The Current Situations and Analysis of Supervision on Medical Devices and Rehabilitation Technical Aids in China

Objective To analyse the features and relevance between medical devices and rehabilitation technical aids and to provide reference for administration system. Methods The medical devices and rehabilitation technical aids in aspects as term, classification, standard and supervision were comparative analyzed. Results and Conclusion At present, the medical devices management in China is not suitable for all of the rehabilitation technical aids. These rehabilitation technical aids in line with the definition of medical device, intended use for medical treatment and belong to the functions of state food and drug administration can he incorporated into medical device management.