inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">一類醫(yī)療器械是指對人體的生理結(jié)構或者生命體征進行監(jiān)測、診斷、治療、緩解、補充或者改變的器械、材料和其他類似或者相關的產(chǎn)品，屬于安全性較低、風險較小的醫(yī)療器械。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">一、準備申請資料

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">申請表：需要填寫申請表并加蓋公章。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">法定代表人或者負責人的身份證明和授權委托書。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">企業(yè)資質(zhì)證明：包括營業(yè)執(zhí)照、組織機構代碼證、稅務登記證、衛(wèi)生許可證等證明材料。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">生產(chǎn)車間、儀器設備、生產(chǎn)工藝、質(zhì)量體系等相關材料。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">二、申請材料審核

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">提交申請材料后，當?shù)厥称匪幤繁O(jiān)督管理部門會對材料進行初步審核，確認申請資料是否齊全、符合要求。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">初審通過后，當?shù)厥称匪幤繁O(jiān)督管理部門會組織現(xiàn)場檢查，確認企業(yè)的生產(chǎn)車間、儀器設備、生產(chǎn)工藝、質(zhì)量體系等是否符合相關規(guī)定。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">三、技術評審

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">當?shù)厥称匪幤繁O(jiān)督管理部門會邀請專家對企業(yè)提交的技術資料進行評審，確定企業(yè)的產(chǎn)品是否符合相關的技術標準和規(guī)范要求。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">技術評審通過后，當?shù)厥称匪幤繁O(jiān)督管理部門會頒發(fā)一類醫(yī)療器械生產(chǎn)許可證。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">四、監(jiān)督檢查

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">企業(yè)獲得一類醫(yī)療器械生產(chǎn)許可證后，需要按照許可證上的內(nèi)容開展生產(chǎn)活動，同時需要遵守相關的法律法規(guī)和技術標準。

inkMacSystemFont, "Helvetica Neue", Arial, "PingFang SC", "PingFang TC", "PingFang HK", "Microsoft Yahei", "Microsoft JhengHei"; white-space: pre-wrap; background-color: rgb(255, 255, 255);">當?shù)厥称匪幤繁O(jiān)督管理部門會對企業(yè)進行定期的監(jiān)督檢查，確認企業(yè)的生產(chǎn)活動是否符合相關規(guī)定