日本医疗器械审评审批信息公开制度的研究

Study on the Disclosure System of the Evaluation and Approval Information of Medical Device Review in Japan

为贯彻落实《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》,推进依法执政,公开审评审批信息,保障公民知情权、监督权势在必行;在保护申请人商业机密和技术机密的同时,公开技术审评报告也有助于打破技术壁垒,促进我国医疗器械行业发展与世界接轨。因此,通过对日本医疗器械审评审批信息公开制度的研究,为我国医疗器械审评审批信息公开提供借鉴和参考。

In order to carry out the “opinions on deepening the reform of the evaluation and approval system and encouraging the innovation of drugs and medical devices” and push on governing by law, it is imperative to disclose the evaluation and approval information of medical device and protect citizens＇ right to know and right to supervision. In addition, while protecting the applicants＇ business secrets and technical secrets, the disclosure of technical evaluation reports will also help to break down technical barriers and promote the development of medical device industry in China that will be connecting with the world. Therefore, through the study on the disclosure system of the evaluation and approval information of medical device review in Japan, it provides references for disclosure of the evaluation and approval information of medical device in our country.