海淀蓟门桥北京医疗器械二类备案医疗器械三类经营许可证全程代办经验丰富周期短Zui快7天下证

三类——国家药监局办理医疗器械许可证 第三类医疗器械是具有较高风险，需要采取特别措施严格控制管理以保证其安全有效的医疗器械，比如常见的输液器、注射器、静脉留置针、心脏支架、呼吸机、CT、核磁共振等，其产品和生产经营活动分别由、省级食品药品监管部门和设区的市食品药品监管部门实行许可管理，分别发给《医疗器械注册证》、《医疗器械生产许可证》、《医疗器械经营许可证》。

北京公司如何办理增加医疗器械经营范围呢?增加医疗器械经营范围有什么要求呢?接下来，徐冰为您详细介绍：

一、公司增加一类医疗器械经营范围

第一类医疗器械是指，通过常规管理足以保证其安全性、有效性的医疗器械。

一类医疗许可证无需办理经营许可证。如果是生产医疗器械，则需要到相关部门备案。

二、公司增加二类医疗器械经营范围

二类医疗器械备案要求，根据《医疗器械监督管理条例》凡是从事二类医疗器械经营的单位都需要到所在地设区的市级食品药品监督管理部门备案，二类医疗器

ou in detail: 1. The company has increased the business scope of class I medical devices The first type of medical devices refer to the medical devices that are sufficient to ensure their safety and effectiveness through routine management. A Class I medical license does not need to apply for a business license. If it is making medical devices, it needs to be filed with the relevant department. 2. The company has increased the business scope of class II medical devices The filing requirements of Class II medical devices, according to the "Regulations on supervision and Administration of Medical Devices", all units engaged in the business of Class II medical devices need to record with the municipal food and drug supervision and administration