預(yù)審：現(xiàn)場(chǎng)審核合格后，醫(yī)療器械監(jiān)督管理部門(mén)將對(duì)申請(qǐng)材料進(jìn)行預(yù)審。

審核：預(yù)審合格后，醫(yī)療器械監(jiān)督管理部門(mén)將進(jìn)行審核，審核包括企業(yè)的組織架構(gòu)、質(zhì)量管理體系、產(chǎn)品銷(xiāo)售情況等方面。

頒發(fā)許可證：審核通過(guò)后，醫(yī)療器械監(jiān)督管理部門(mén)將頒發(fā)醫(yī)療器械經(jīng)營(yíng)許可證。

申請(qǐng)三類(lèi)醫(yī)療器械經(jīng)營(yíng)許可證需要滿(mǎn)足相關(guān)的資質(zhì)要求和管理要求，申請(qǐng)過(guò)程比較復(fù)雜，建議企業(yè)在申請(qǐng)前了解相關(guān)政策法規(guī)，以及咨詢(xún)專(zhuān)業(yè)的醫(yī)療器械代辦公司或律師事務(wù)所，提高申請(qǐng)成功率

隨著相關(guān)制度的逐步完善，市場(chǎng)環(huán)境的逐漸向好，醫(yī)療器械或?qū)⒂瓉?lái)噴涌爆發(fā)式的發(fā)展。

新政策要求：醫(yī)療器械經(jīng)營(yíng)企業(yè)要在經(jīng)營(yíng)活動(dòng)中積極應(yīng)用唯一標(biāo)識(shí)，做好帶碼入庫(kù)、出庫(kù)，實(shí)現(xiàn)產(chǎn)品在流通環(huán)節(jié)可追溯。

醫(yī)療器械經(jīng)營(yíng)許可證申請(qǐng)須知

醫(yī)療器械經(jīng)營(yíng)許可證是醫(yī)療器械經(jīng)營(yíng)企業(yè)必須具備的，開(kāi)辦第二類(lèi)醫(yī)療器械經(jīng)營(yíng)企業(yè)，應(yīng)當(dāng)向省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)備案；

開(kāi)辦第三類(lèi)醫(yī)療器械經(jīng)營(yíng)企業(yè)，應(yīng)當(dāng)經(jīng)省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門(mén)審查批準(zhǔn)，并發(fā)給《醫(yī)療器械經(jīng)營(yíng)許可證》。

依據(jù)《醫(yī)療器械經(jīng)營(yíng)監(jiān)督管理辦法》，開(kāi)設(shè)三類(lèi)醫(yī)療器械運(yùn)營(yíng)公司，食品類(lèi)藥品監(jiān)督管理局單位將會(huì)對(duì)經(jīng)營(yíng)地開(kāi)展當(dāng)場(chǎng)審查。對(duì)不符合要求標(biāo)準(zhǔn)的，明確提出整頓規(guī)定或未予批準(zhǔn)。根據(jù)《藥品醫(yī)療器械飛行檢查辦法》，食品類(lèi)藥品監(jiān)督管理局單位將會(huì)對(duì)醫(yī)療機(jī)械銷(xiāo)貨方式合理合法、工作人員在職人員在職、拿貨檢查、運(yùn)送儲(chǔ)存等層面開(kāi)展不事先告之的監(jiān)督管理。三類(lèi)醫(yī)療器械的界定

nt department will conduct an audit, including the organizational structure, management system, product sales, etc. License issuance: After the approval, the medical device supervision and administration department will issue the medical device business license. The application for the business license of Class III medical devices should meet the relevant re and management re, and the application process is complicated. It is suggested that enterprises understand the relevant policies and regulations before the application, as well as consult professional medical device agency companies or law firms, so as to improve the success rate of the application With the gradual improvement of relevant systems and the gradual improvement of the market environment, medical devices may usher in the explosive development. The new policy re: medical device operating enterprises should actively apply the unique identification in their business activities, do a good job of warehousing and warehousing with codes, and realize the traceability of products in the circulation link. Instructions for application for medical Device Busi