朝阳水碓子北京医疗器械三类经营许可证,医疗器械二类备案提供人员库房专业快捷包下证

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
2023-11-04 00:00

详细介绍

2、法律依据:《医疗器械监督管理条例》第十四条
第一类医疗器械产品备案和申请第二类、第三类医疗器械产品注册,应当提交下列资料:
(一)产品风险分析资料;
(二)产品技术要求;
(三)产品检验报告;办理三类医疗器械经营许可证的办理流程:
5、三类医疗器械经营许可证,需要直接去市级人民政府食品药品监督管理部门办理,在接受资料后的30天内进行审核,如果符合相关规定,就可以颁发三类医疗器械经营许可证。

医疗企业经营许可证一共有三类,其中办理一类医疗器械许可证可以直接办理,经营二类产品是需要办理二类医疗器械经营备案凭证,经营三类产品则需要办理三类医疗器械经营许可证。

首先,经营企业必须明确申请三类医疗器械经营许可证的条件并满足相关要求。

(一)具有与经营规模和经营范围相适应的质量管理机构或者质量管理人员两个。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,质量管理人应在职在岗,不得在其他单位兼职;

(二)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;

(三)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;

of class iii medical devices shall go directly to the food anddrug regulatory department of the municipal people's government,and review within 30 days after receiving the data, if the relevantprovisions are met, the business license of class iii medicaldevices can be issued. there are three types of medical enterprisebusiness licenses, among which the first class medical devicelicense can be directly handled, the operation of second classproducts needs to apply for the record certificate of second classmedical devices, and the operation of third class products needs toapply for the business license of third class medical devices.first of all, the operating enterprise must clarify the conditionsfor applying for the third type of medical device business licenseand meet the relevant re (1) it shall have two agencies or control personnel suitable for thescale and scope of its business operations. the managementpersonnel shall have relevant professional orprofessional titles recognized by the state, and the manager shall be on duty and shall not take part-time jobs in otherunits; (2) having a relatively independent business sitecommensurate with the scale and scope of operation; (3) it shallhave storage conditions commensurate with the scale and scope ofbusiness, including storage facilities and e that meet there of the characteristics of the medical device 


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