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

那么在北京如何辦理三類醫(yī)療經營許可證，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與您分享。

三類醫(yī)療器械常見產品有哪些：

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

三類申請醫(yī)療器械經營許可證條件：

1.具有與經營規(guī)模和經營范圍相適應的質量管理機構或者專職質量管理人員。質量管理人員應當具有國家認可的相關專業(yè)學歷或者職稱；

2.具有與經營規(guī)模和經營范圍相適應的相對獨立的經營場所；

3.具有與經營規(guī)模和經營范圍相適應的儲存條件，包括具有符合醫(yī)療器械產品特性要求的儲存設施、設備；

 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, microwa