关键词: font-size:medium, ">医疗器械；科学监管；口腔铸造合金；检测数据；智慧审评； 智慧监管

Abstract: Scientific supervision of medical devices is an important topic to ensure the safety of medical devices. Many countries make endeavor to intelligent evaluation and intelligent supervision of medical devices. However， intelligent evaluation and intelligent supervision are based on the big data of medical devices. Although China has established a series of databases related to medical devices， such as review and approval database， post-marketing adverse reactions database and standards database， which has provided effective support for pre-market review and post-market supervision， those data from the whole life cycle of medical devices still need to be collected and analysed. This study rearranged the data of dental casting alloy from the Dental Medical Device Inspection Center of Peking University School of Stomatology， combined the medical device product information of China Data Center For Food and Drug Administration， try to establish the medical device test performance database， and explore the feasibility of the medical device test data collecting， sorting， analyzing and reusing，so as to provide data support for the scientific supervision of dental casting alloy, and provide reference for the establishment of corresponding database in medical device inspection centers.

Key words: font-size:medium, ">Medical device； Scientific supervision； Oral casting alloy； Test data； Intelligent review； Intelligent supervision