seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">對于第二類(lèi)醫療器械經(jīng)營(yíng)備案人員有要求：

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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">1、法人兼任企業(yè)負責人的需要有大專(zhuān)以上學(xué)歷，不做要求；

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">2、質(zhì)量負責人需要有3年以上工作經(jīng)驗，大專(zhuān)以上學(xué)歷，相關(guān)畢業(yè)；

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">醫療器械相關(guān)指：醫療器械、生物醫學(xué)工程、機械、電子、醫學(xué)、生物工程、化學(xué)、護理學(xué)、康復、檢驗學(xué)、管理、計算機等

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">三、對于第二類(lèi)醫療器械經(jīng)營(yíng)備案材料有要求：

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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">1、第二類(lèi)醫療器械經(jīng)營(yíng)備案申請表

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">2、營(yíng)業(yè)執照和組織機構代碼證復印件；

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">3、法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明、學(xué)歷或者職稱(chēng)證明復印件；

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">4、組織機構與部門(mén)設置說(shuō)明；

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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">5、經(jīng)營(yíng)范圍、經(jīng)營(yíng)方式說(shuō)明

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">6、經(jīng)營(yíng)場(chǎng)所、庫房地址的地理位置圖、平面圖、房屋產(chǎn)權證明文件或者租賃協(xié)議（附房屋產(chǎn)權證明文件）復印件；

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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">7、經(jīng)營(yíng)設施、設備目錄；

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">

seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">8、經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄；

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seline; line-height: 2; word-break: break-all; overflow-wrap: break-word; white-space: normal; background-color: rgb(255, 255, 255);">9、經(jīng)辦人授權證明；