(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;10、申请材料应完整、清晰、签字,并逐份加盖公章,所有申请表格电脑打字填写,使用A4纸打印,复印使用A4纸,按照申请材料目录顺序装订成册。申请人隐瞒有关情况或者提供虚假材料的,省、自治区、直辖市(食品)药品监督管理部门或者接受委托的设区的市级(食品)药品监督管理机构对申请不予受理或者不予核发《医疗器械经营企业许可证》,并给予警告。申请人在1年内不得申请《医疗器械经营企业许可证》。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。申请人在3年内不得
risk analysis data; (2) product technical requirements; (3)product inspection report; (4) clinical evaluation data; 10. Theapplication materials shall be complete, clear, signed, stampedwith official seal, all application forms shall be filled in bycomputer, printed on A4 paper, copied on A4 paper, and bound inorder with the list of application materials. Where the applicantconceals the relevant information or provides false materials, the(food) drug regulatory department of the province, autonomousregion or municipality directly under the Central Government or the(food) drug regulatory agency of the entrusted city shall notaccept the application or issue the Medical Device TradingEnterprise License and give it a warning. The applicant shall notapply for the Medical Device Business Enterprise License againwithin one year. Where the applicant obtains the Medical DeviceTrading Enterprise License by improper means of cheating orbribery, the (food) and drug regulatory department shall revoke theMedical Device Trading Enterprise License, give a warning andimpose a fine of not less than 10,000 yuan but not morethan