三类医疗器械经营许可证如何办理
1、三类医疗器械经营许可证办理方式如下:
(1)申请人提交申请资料到相关部门;
(2)相关部门受理申请人的申请;
(3)到实际场地进行勘察以及对产品进行审核;
(4)准予颁发三类医疗器械许可证。
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;
(四)临床评价资料;
(五)产品说明书以及标签样稿;申请人隐瞒有关情况或者提供虚假材料的,省、
办理三类医疗器械经营许可证的条件如下:(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;(四)应当建立健全产品质量管理制度,包括采购、进货验收、仓储保管、出库复核、质量跟踪制度和不良事件的报告制度等;(五)应当具备与其经营的医疗器械产品相适应的
roduct inspection report; (4) clinical evaluation data; (5) product specification and label samples; Where the applicant conceals the relevant information or provides false materials, The conditions for applying for the business license of three-class medical devices are as follows: (1) it professional titles recognized by the state, Quality managers should be on the job, Do not take part-time jobs in other units; (2) having a relatively independent business site commensurate with the scale and scope of operation; (3) having the storage conditions suitable for the scale and scope of business, Including storage facilities and equipment that meet the characteristic requirements of medical devices; (4) A product quality control system shall be established and improved, Including procurement, purchase acceptance, storage, warehouse review, quality tracking system and adverse event reporting system; (5) those that should be suitable for the medical devices it operatesmanagement personnel shall have relevant professional qualifications or professional titles recognized by the state, Quality managers should be on the job,
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