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;申请人以欺骗、贿赂等不正当手段取得《医疗器械经营企业许可
ndle the business license of the medical device? 1. The businesslicense of the third class medical device is as follows: (1) theapplicant submits the application materials to the relevantdepartments; (2) the relevant departments accept the application ofthe applicant; (3) investigate the actual site and review theproduct; (4) grant the issuance of the third class medical devicelicense.2. Legal basis: Article 14 of the Regulations onSupervision and Administration of Medical Devices For the filing ofClass I medical devices and the application for the registration ofClass II and Class III medical devices, the following materialsshall be submitted: (1) product risk analysis data; (2) producttechnical requirements; (3) product inspection report; (4) clinicalevaluation data; (5) product description and label samples; theapplicant shall obtain the license of the medical device tradingenterprise by cheating, bribery or other improper means