许可证》。经营活动由设区的市级食品药品监管部门实行备案管理;
03.
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国家zongju、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?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
sing the business scope of medical devices? Next, Xu Bing willintroduce it to you in detail: 1. The company has increased thebusiness scope of class I medical devices The first type of medicaldevices refer to the medical devices that are sufficient to ensuretheir safety and effectiveness through routine management. A ClassI medical license does not need to apply for a business license. Ifit is making medical devices, it needs to be filed with therelevant department. 2. The company has increased the businessscope of class II medical devices