北京通州北京醫(yī)療器械三類經(jīng)營(yíng)許可證，醫(yī)療器械二類備案提供進(jìn)銷存軟件庫(kù)房速度快專業(yè)包下證

1、三類醫(yī)療器械經(jīng)營(yíng)許可證辦理方式如下：
（1）申請(qǐng)人提交申請(qǐng)資料到相關(guān)部門(mén)；
（2）相關(guān)部門(mén)受理申請(qǐng)人的申請(qǐng)；
（3）到實(shí)際場(chǎng)地進(jìn)行勘察以及對(duì)產(chǎn)品進(jìn)行審核；
（4）準(zhǔn)予頒發(fā)三類醫(yī)療器械許可證。
2、法律依據(jù)：《醫(yī)療器械監(jiān)督管理?xiàng)l例》第十四條
第一類醫(yī)療器械產(chǎn)品備案和申請(qǐng)第二類、第三類醫(yī)療器械產(chǎn)品注冊(cè)，應(yīng)當(dāng)提交下列資料：
（一）產(chǎn)品風(fēng)險(xiǎn)分析資料；
（二）產(chǎn)品技術(shù)要求；
（三）產(chǎn)品檢驗(yàn)報(bào)告；
（四）臨床評(píng)價(jià)資料；
（五）產(chǎn)品說(shuō)明書(shū)以及標(biāo)簽樣稿；
（六）與產(chǎn)品研制、生產(chǎn)有關(guān)的質(zhì)量管理體系文件；1、經(jīng)營(yíng)企業(yè)提交的《醫(yī)療
醫(yī)療器械經(jīng)營(yíng)許可證。

醫(yī)療企業(yè)經(jīng)營(yíng)許可證一共有三類，其中辦理一類醫(yī)療器械許可證可以直接辦理，經(jīng)營(yíng)二類產(chǎn)品是需要辦理二類醫(yī)療器械經(jīng)營(yíng)備案憑證，經(jīng)營(yíng)三類產(chǎn)品則需要辦理三類醫(yī)療器械經(jīng)營(yíng)許可證。經(jīng)營(yíng)企業(yè)必須明確申請(qǐng)三類醫(yī)療器械經(jīng)營(yíng)許可證的條件并滿足相關(guān)要求。（一）具有

pplicant submits the application materials to the relevant departments; (2) the relevant departments accept the application of the applicant; (3) investigate the actual site and review the products; (4) grant the issuance of class III medical device license.2. Legal basis: Article 14 of the Regulations on Supervision and Administration of Medical Devices for the filing of Class I medical devices and the application for the registration of Class II and III medical devices, the following materials shall be submitted: (1) product risk analysis data; (2) product technical re; (3) product inspection report; (4); (5) clinical evaluation data; product description and label samples; (6) management system documents related to product development and production; 1. Business license of