顺义新国展医疗器械三类经营许可证二类备案专业办理快捷包下证

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。

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证》的，（食品）药品监督管理部门应当撤销其《医疗器械经营企业许可证》，给予警告，并处1万元以上2万元以下罚款。申

issuance of a class III medical device license. 2. Legal basis:Article 14 of the Regulations on the Supervision and Administrationof Medical Devices As for the registration of Class II and IIImedical devices, the following materials shall be submitted: (1)Product risk analysis data; (2) Technical requirements for theproducts; (3) Product inspection report; (4) Clinical evaluationdata; (5) Product specification and label samples; (6) qualitymanagement system documents related to product development andproduction; (7) other materials required to prove the safety andeffectiveness of the product. Where the applicant obtains theMedical Device Trading Enterprise License by improper means ofcheating or bribery, the (food) and drug regulatory departmentshall revoke the Medical Device Trading Enterprise License, give awarning and impose a fine of not less than 10,000 yuan but not morethan 20,000 yuan.st