中美医疗器械指导原则格式对比研究

Comparative Study of Guidance Format of Medical Device for China and America

目的通过对中美医疗器械指导原则的研究,为完善和发展我国医疗器械指导原则格式提供借鉴。方法采用内容翻译和归纳法,对医疗器械指导原则格式进行分析。结果和结论 FDA的医疗器械指导原则有通用、信函、问答3种格式,通用格式使用较多。产品的指导原则大多采用通用格式,解释政策或某一具体问题采用信函式或问答式。FDA根据具体内容采用不同的格式编写指导原则。我国的指导原则只有一种格式,即为具体产品注册申报用的指导原则格式,格式少,结构简单,通过比较中美医疗器械指导原则的格式和结构,以期为完善我国医疗器械指导原则的格式和结构提供参考。

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.