申請三類醫(yī)療器械經(jīng)營許可證需要滿足相關(guān)的資質(zhì)要求和管理要求，申請過程比較復(fù)雜，建議企業(yè)在申請前了解相關(guān)政策法規(guī)，以及咨詢專業(yè)的醫(yī)療器械代辦公司或律師事務(wù)所，提高申請成功率

隨著相關(guān)制度的逐步完善，市場環(huán)境的逐漸向好，醫(yī)療器械或?qū)⒂瓉韲娪勘l(fā)式的發(fā)展。

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

醫(yī)療器械經(jīng)營許可證申請須知

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

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

依據(jù)《醫(yī)療器械經(jīng)營監(jiān)督管理辦法》，開設(shè)三類醫(yī)療器械運營公司，食品類藥品監(jiān)督管理局單位將會對經(jīng)營地開展當(dāng)場審查。對不符合要求標(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》，食品類藥品監(jiān)督管理局單位將會對醫(yī)療機(jī)械銷貨方式合理合法、工作人員在職人員在職、拿貨檢查、運送儲存等層面開展不事先告之的監(jiān)督管理。三類醫(yī)療器械的界定

rofessional 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 Business License The medical device business license is necessary for the medical device trading enterprise, and the establishment of the second class medical device trading