丰台马家堡北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件库房速度快专业方便。

我公司主要经营代办北京医疗器械公司注册|代办北京三类医疗器械公司注册|代办北京二类医疗器械备案凭证|代办北京食品经营许可证|代办北京医疗器械网络备案|代办北京辐射安全许可等资质专项审批服务

三类医疗器械指的是植入人体，用于支持、维持生命，对人体具有潜在危险，对其安全性、有效性必须严格控制的医疗器械。现行制度规范下，经营三类医疗器械的经营主体需要按程序办理三类医疗器械经营许可证。

那么在北京如何办理三类医疗经营许可证，办理许可证又有哪些条件及流程，小编今天带着满满的干货知识与您分享。

三类医疗器械常见产品有哪些：

植入式心脏起搏器、体外震波碎石机、病人有创监护系统、人工晶体、有创内窥镜、超声手术刀、彩色超声成像设备、激光手术设备、高频电刀、微波缓解仪、医用核磁共振成像设备、X线缓解设备、医用高能设备、人工心肺机、内固定器材、人工心脏瓣膜、人工肾、呼吸麻醉设备、一次性使用无菌注射器、一次性使用输液器、输血器、CT等。

三类申请医疗器械经营许可证条件：

1.具有与经营规模和经营范围相适应的质量管理机构或者专职质量管理人员。质量管理人员应当具有国家认可的相关专业学历或者职称；

2.具有与经营规模和经营范围相适应的相对独立的经营场所；

3.具有与经营规模和经营范围相适应的储存条件，包括具有符合医疗器械产品特性要求的储存设施、设备；

k for the record | Beijing radiation safety license qualification special examination and approval services Class III medical devices refer to the medical devices implanted in human body to support and maintain 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 equipment, laser surgery equipment, high frequency electric knife, microwave relief instrument, medical nuclear magnetic resonance imaging equipment, X-ray relief equipment, medical high-energy equipment, artificial heart-lung machine, internal fixation equipment, artificial heart valve, artificial kidney, respiratory anesthesia equipment, disposable sterile syringe, disposable infusion set, blood transfusion device, CT, etc. Conditions for applying for the Medical Device Business License: 1. It shall have a quality management institution or full-time quality management personnel suitable for the business scale and business scope. The quality management personnel shall have the relevant professional academic qualifications or professional titles recognized by the state; 2. Having a relatively independent bu