三類醫(yī)療器械指的是植入人體，用于支持、維持生命，對(duì)人體具有潛在危險(xiǎn)，對(duì)其安全性、有效性必須嚴(yán)格控制的醫(yī)療器械。現(xiàn)行制度規(guī)范下，經(jīng)營三類醫(yī)療器械的經(jīng)營主體需要按程序辦理三類醫(yī)療器械經(jīng)營許可證。

那么在北京如何辦理三類醫(yī)療經(jīng)營許可證，辦理許可證又有哪些條件及流程，小編今天帶著滿滿的干貨知識(shí)與您分享。

三類醫(yī)療器械常見產(chǎn)品有哪些：

植入式心臟起搏器、體外震波碎石機(jī)、病人有創(chuàng)監(jiān)護(hù)系統(tǒng)、人工晶體、有創(chuàng)內(nèi)窺鏡、超聲手術(shù)刀、彩色超聲成像設(shè)備、激光手術(shù)設(shè)備、高頻電刀、微波緩解儀、醫(yī)用核磁共振成像設(shè)備、X線緩解設(shè)備、醫(yī)用高能設(shè)備、人工心肺機(jī)、內(nèi)固定器材、人工心臟瓣膜、人工腎、呼吸麻醉設(shè)備、一次性使用無菌注射器、一次性使用輸液器、輸血器、CT等。

三類申請(qǐng)醫(yī)療器械經(jīng)營許可證條件：

1.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)或者專職質(zhì)量管理人員。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；

2.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的相對(duì)獨(dú)立的經(jīng)營場(chǎng)所；

3.具有與經(jīng)營規(guī)模和經(jīng)營范圍相適應(yīng)的儲(chǔ)存條件，包括具有符合醫(yī)療器械產(chǎn)品特性要求的儲(chǔ)存設(shè)施、設(shè)備；

4.應(yīng)當(dāng)建立健全產(chǎn)品質(zhì)量管理制度，包括采購、進(jìn)貨驗(yàn)收、倉儲(chǔ)保管、出庫復(fù)核、質(zhì)量跟蹤和不良事件的報(bào)告制度等；

 life, with potential danger to human body, and their safety and effectiveness must be strictly controlled. Under the current system and norms, the business entities of third class medical devices need to apply for the business license of third class medical devices according to the procedures. So in Beijing how to apply for the three types of medical business license in Beijing, what are the conditions and procedures for the license, Xiaobian today with full of dry knowledge to share with you. What are the common products of Class III medical devices: Implantable cardiac pacemaker, external shock wave lithotripsy machine, patient invasive monitoring system, artificial lens, invasive endoscope, ultrasonic scalpel, color ultrasound imaging e, laser surgery e, high frequency electric knife, microwave relief instrument, medical nuclear magnetic resonance imaging e, X-ray relief e, medical high-energy e, artificial heart-lung machine, internal fixation e, artificial