海淀安宁庄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Zui快7天下证
- 供应商
- 北京星期三企业管理咨询有限公司业务部
- 认证
- 医疗器械三类
- 注册
- 医疗器械二类
- 注册
- 注册公司
- 网络销售备案
- 联系电话
- 15501182773
- 手机号
- 15501182773
- 联系人
- 马胜辉
- 所在地
- 北京市海淀区清河嘉园东区甲1号楼11层1124
- 更新时间
- 2024-02-29 13:58
冰袋、降温贴等,其产品和生产活动由所在地设区的市级食品药品监管部门实行备案管理。经营活动则全部放开,既不用许可也不用备案,只需取得工商部门核发的营业执照即可。
02.
二类——市药监局办理医疗器械经营备案第二类医疗器械是具有中度风险,需要严格控制管理以保证其安全有效的医疗器械,比如我们日常生活中常见的创可贴、避孕套、体温计、血压计、制氧机、雾化器等,其产品和生产活动由省级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》和《医疗器械生产许可证》。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、
cts and production activities of ice packs and cooling stickersshall be managed by the food and drug regulatory departments of thecity divided into districts. business activities are all open,neither need to put on record, only need to obtain the businesslicense issued by the industry and commerce department. 02. class—— municipal food and drug administration for medical devicebusiness for the second type of medical e is a moderaterisk, need to strictly control management to ensure its safe andeffective medical devices, such as our daily life, band, condoms,thermometer, blood monitor, oxygen generator, atomizer, itsproducts and production activities by the provincial food and drugregulatory department licensing management, respectively issued tothe medical device registration certificate and medicaldevice