关键词: 矫形器, 医疗器械, 康复辅具

Abstract: Objective To discuss the key problem of medical device supervision of orthoses and its effect on orthoses market. Methods The meaning of orthoses was discriminated, the status of regulation was revealed, the generic names of orthoses was designed, and the effect of supervision on different body of orthoses market was analyzed. Results Difficulties are brought to the medical device regulation because of different meanings of orthoses in the fields of assistive devices and medical devices. Scientific classification and naming was the right way to solve the problem. Conclusion All the organizations on chains of orthoses are within the category of medical device supervision. Fitting organizations of orthoses should also accept regulation of China Food and Drug Administration, at the same time gaining qualification from China Ministry of Civil Affairs. The problem of personalized orthoses supervision needs to be solved properly.

Key words: orthoses, medical devices, assistive devices