預審：現場(chǎng)審核合格后，醫療器械監督管理部門(mén)將對申請材料進(jìn)行預審。

審核：預審合格后，醫療器械監督管理部門(mén)將進(jìn)行審核，審核包括企業(yè)的組織架構、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，醫療器械監督管理部門(mén)將頒發(fā)醫療器械經(jīng)營(yíng)許可證。

申請三類(lèi)醫療器械經(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，申請過(guò)程比較復雜，建議企業(yè)在申請前了解相關(guān)政策法規，以及咨詢(xún)專(zhuān)業(yè)的醫療器械代辦公司或律師事務(wù)所，提高申請成功率

隨著(zhù)相關(guān)制度的逐步完善，市場(chǎng)環(huán)境的逐漸向好，醫療器械或將迎來(lái)噴涌爆發(fā)式的發(fā)展。

新政策要求：醫療器械經(jīng)營(yíng)企業(yè)要在經(jīng)營(yíng)活動(dòng)中積極應用唯一標識，做好帶碼入庫、出庫，實(shí)現產(chǎn)品在流通環(huán)節可追溯。

醫療器械經(jīng)營(yíng)許可證申請須知

醫療器械經(jīng)營(yíng)許可證是醫療器械經(jīng)營(yíng)企業(yè)必須具備的，開(kāi)辦第二類(lèi)醫療器械經(jīng)營(yíng)企業(yè)，應當向省、自治區、直轄市人民政府藥品監督管理部門(mén)備案；

開(kāi)辦第三類(lèi)醫療器械經(jīng)營(yíng)企業(yè)，應當經(jīng)省、自治區、直轄市人民政府藥品監督管理部門(mén)審查批準，并發(fā)給《醫療器械經(jīng)營(yíng)許可證》。

依據《醫療器械經(jīng)營(yíng)監督管理辦法》，開(kāi)設三類(lèi)醫療器械運營(yíng)公司，食品類(lèi)藥品監督管理局單位將會(huì )對經(jīng)營(yíng)地開(kāi)展當場(chǎng)審查。對不符合要求標準的，明確提出整頓規定或未予批準。根據《藥品醫療器械飛行檢查辦法》，食品類(lèi)藥品監督管理局單位將會(huì )對醫療機械銷(xiāo)貨方式合理合法、工作人員在職人員在職、拿貨檢查、運送儲存等層面開(kāi)展不事先告之的監督管理。三類(lèi)醫療器械的界定

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