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;
(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
s III medical device 1. The business license of Class IIImedical device is as follows: (1) the applicant submits theapplication materials to the relevant department; (2) the relevantdepartment accepts the application of the applicant; (3)investigate the actual site and review the product; (4) grant theissuance of the Class III medical device license.2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical devices and applying for the registration of Class IIand Class III medical devices, the following materials shall besubmitted: (1) product risk analysis data; (2) product technicalrequirements; (ii) product inspection report; (4) clinicalevaluation; (4) clinical evaluation data; (3) having storageconditions suitable to the business scale and business scope,including storage facilities and equipment that meet thecharacteristics of medical devices; (4) The product qualitymanagement system shall be established and improved, includingprocurement, purchase acceptance, storage, warehouse review,quality tracking system and defective