（1）申請人提交申請資料到相關(guān)部門；
（2）相關(guān)部門受理申請人的申請,；
（3）到實(shí)際場地進(jìn)行勘察以及對產(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)品備案和申請第二類,、第三類醫(yī)療器械產(chǎn)品注冊，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）臨床評價(jià)資料,；
（五）產(chǎn)品說明書以及標(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)營企業(yè)提交的《醫(yī)療
醫(yī)療器械經(jīng)營許可證。

醫(yī)療企業(yè)經(jīng)營許可證一共有三類,，其中辦理一類醫(yī)療器械許可證可以直接辦理,，經(jīng)營二類產(chǎn)品是需要辦理二類醫(yī)療器械經(jīng)營備案憑證，經(jīng)營三類產(chǎn)品則需要辦理三類醫(yī)療器械經(jīng)營許可證。首先,，經(jīng)營企業(yè)必須明確申請三類醫(yī)療器械經(jīng)營許可證的條件并滿足相關(guān)要求,。（一）具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者質(zhì)量管理人員兩個(gè)。質(zhì)量管理人員應(yīng)當(dāng)具有國家認(rèn)可的相關(guān)專業(yè)學(xué)歷或者職稱,，質(zhì)量管理人應(yīng)在職在崗,，不得在其他單位兼職；（二）具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的相對獨(dú)立

 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 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 medical and medical devices submitted by the operating enterprise. There are three types of medical enterprise business licenses, among which the first class medical device license can be directly handled, the operation of second class products needs to apply for the record certificate of second class medical devices, and the operation of third class products needs to apply for the business license of third class medical devices. First of