北京大兴北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富靠谱周期短Zui快7天下证

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

l devices implanted in human body to support and maintain life,with potential danger to human body, and their safety andeffectiveness must be strictly controlled. Under the current systemand norms, the business entities of third class medical devicesneed to apply for the business license of third class medicaldevices according to the procedures. So in Beijing how to apply forthe three types of medical business license in Beijing, what arethe conditions and procedures for the license, Xiaobian today withfull of dry knowledge to share with you. What are the commonproducts of Class III medical devices: Implantable cardiacpacemaker, external shock wave lithotripsy machine, patientinvasive monitoring system, artificial lens, invasive endoscope,ultrasonic scalpel, color ultrasound imaging equipment, lasersurgery