許可程序：一、申請(qǐng)與受理?xiàng)l件企業(yè)登陸 北京市食品藥品監(jiān)督管理局企業(yè)服務(wù)平臺(tái)進(jìn)行網(wǎng)上申報(bào)( 網(wǎng)上填報(bào)指南)，企業(yè)根據(jù)受理范圍的規(guī)定，需提交以下申請(qǐng)材料：1．《 醫(yī)療器械經(jīng)營(yíng)許可申請(qǐng)表》；2．營(yíng)業(yè)執(zhí)照復(fù)印件（交驗(yàn)原件）； 3．法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身f證明、學(xué)歷或者職稱證明復(fù)印件；（交驗(yàn)原件） 4．組織機(jī)構(gòu)與部門設(shè)置說(shuō)明； 5．經(jīng)營(yíng)場(chǎng)所、庫(kù)房的地理位置圖、平面圖（注明面積）；庫(kù)房的產(chǎn)權(quán)證明及使用權(quán)證明復(fù)印件；（委托貯存的，應(yīng)提交經(jīng)營(yíng)場(chǎng)所地理位置圖、平面圖（注明面積）和與被委托方簽署的書面協(xié)議復(fù)印件、被委托方的《醫(yī)療器械經(jīng)營(yíng)許可證》復(fù)印件） 6．經(jīng)營(yíng)設(shè)施、設(shè)備目錄； 7．經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄； 8．計(jì)算機(jī)信息管理系統(tǒng)基本情況介紹和功能說(shuō)明； 9．凡申請(qǐng)企業(yè)申報(bào)材料時(shí)，具體辦理人員不是法定代表人或負(fù)責(zé)人本人，企業(yè)應(yīng)當(dāng)提交《 授權(quán)委托書》

Beijing for the medical device business license process of Beijing medical device second class record network record

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