Objective:To study the regulatory system of software as medical devices in US,Japan and China,so as to provide references and suggestions for further perfecting the regulatory system of software as medical devices in China.Methods:Taking US,Japan and China's regulatory systems of software as medical devices as the research object,the US,Japan and China's definitions,classifications and registration regulatory system framework of medical device software were sorted out through literature research.Results and Conclusion:The core ideas of regulatory systems of software as medical device in US and Japan are both based on pre-evaluation and pre-change ideas.Specifically,the US attempts to cancel the approval process before listing,research targeted review methods jointly with multinational and cross-industry institutions;Japan simplifies the approval process before listing and conducts targeted institutional reforms.Both of them may be important references for further improving China's regulatory system of software as medical device.
关键词
医疗器械软件/医疗器械/软件/监管/注册
Key words
software as a medical device/medical device/software/regulation/registration
维普
万方数据