关键词: 医疗器械, 指导原则, 格式 , 结构

Abstract: Objective Based on the research of the medical device guidances of China and the United States, to provide references for the improvement and development of medical devices guidance development format in China． Methods By guidance translation and inductive method, the FDA medical devices in the form of guidelines and format were analyzed. Results and Conclusion The FDA medical device guidance has general format, letter format, question-and-answer format, mostly using the general format. The guidance of the specific products mostly uses the general format, the guidance of explaining policy or a particular problem uses letters format or question-and-answer format. The FDA writes guidance according to specific content in different format. There is only one format of guidance in our country, namely the guidance format for the specific product registration, format is little, structure is simple. Through comparing the guidance format and structure of medical devices, references to perfect our country guidance format and structure of medical devices are provided.

Key words: medical device, guidance, format, structure