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(duì)人體的生理結(jié)構(gòu)或者生命體征進(jìn)行監(jiān)測(cè)、診斷、治療、緩解、補(bǔ)充或者改變的器械、材料和其他類似或者相關(guān)的產(chǎn)品，屬于安全性較低、風(fēng)險(xiǎn)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(zhǔn)備申請(qǐng)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(qǐng)表：需要填寫申請(qǐng)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(fù)責(zé)人的身份證明和授權(quán)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(yíng)業(yè)執(zhí)照、組織機(jī)構(gòu)代碼證、稅務(wù)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(shè)備、生產(chǎn)工藝、質(zhì)量體系等相關(guān)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(qǐng)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(qǐng)材料后，當(dāng)?shù)厥称匪幤繁O(jiān)督管理部門會(huì)對(duì)材料進(jìn)行初步審核，確認(rèn)申請(qǐng)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?fù)ㄟ^后，當(dāng)?shù)厥称匪幤繁O(jiān)督管理部門會(huì)組織現(xiàn)場(chǎng)檢查，確認(rèn)企業(yè)的生產(chǎn)車間、儀器設(shè)備、生產(chǎn)工藝、質(zhì)量體系等是否符合相關(guān)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(shù)評(píng)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(dāng)?shù)厥称匪幤繁O(jiān)督管理部門會(huì)邀請(qǐng)專家對(duì)企業(yè)提交的技術(shù)資料進(jìn)行評(píng)審，確定企業(yè)的產(chǎn)品是否符合相關(guān)的技術(shù)標(biāo)準(zhǔn)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(shù)評(píng)審?fù)ㄟ^后，當(dāng)?shù)厥称匪幤繁O(jiān)督管理部門會(huì)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(dòng)，同時(shí)需要遵守相關(guān)的法律法規(guī)和技術(shù)標(biāo)準(zhǔn)。

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(dāng)?shù)厥称匪幤繁O(jiān)督管理部門會(huì)對(duì)企業(yè)進(jìn)行定期的監(jiān)督檢查，確認(rèn)企業(yè)的生產(chǎn)活動(dòng)是否符合相關(guān)規(guī)定