海淀学院路医疗器械三类经营许可证二类备案专业办理快捷包下证

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；
（六）与产品研制、生产有关的质量管理体系文件；
（七）证明产品安全、有效所需的其他资料。

医疗器械经营许可证是医疗器械经营企业必须具备的，开办第二类医疗器械经营企业，应当向省、自治区、直辖市人民政府药品监督管理部门备案；

开办第三类医疗器械经营企业，应当经省、自治区、直辖市人民政府药品监督管理部门审查批准，并发给《医疗器械经营许可证》。

依据《医疗器械经营监督管理办法》，开设三类医疗器械运营公司，食品类药品监督管理局单位将会对经营地开展当场审查。对不符合要求标准的，明确提出整顿规定或未予批准。根据《药品医疗器械飞行检查办法》

ow to handle the license 1. handling the business license ofclass iii medical devices is as follows: (1) the applicant submitsthe application materials to the relevant departments; (2) therelevant departments accept the application of the applicant; (3)investigate the actual site and review the product; (4) grant theissuance of the license of class iii medical devices.2. legalbasis: article 14 of the regulations on supervision andadministration of medical devices for the filing of class i medicaldevices and application for the registration of class ii and iiimedical devices shall submit the following materials: (1) productrisk analysis data; (2) technical re (3) product; (3)product inspection report; (4) clinical evaluation data; (5)product instructions and label samples; (6) managementsystem documents related to product development and production; (7)other materials required to prove the safety and effectiveness ofthe product. the medical device business license is necessary forthe medical device trading enterprise, and the establishment of thesecond class medical device trading enterprise shall be filed bythe drug regulatory department of the people's government of theprovincial, autonomous region or municipality directly under thecentral government; the establishment of a class iii medical devicetrading enterprise shall be examined and approved by the drugregulatory department of the people's government of the