机关申请;申请材料存在可以当场更正的错误的，应当允许申请人当场更正;申请材料不齐全或者不符合法定形式的，应当当场或者在五日内一次告知申请人需要补正的全部内容，逾期不告知的，自收到申请材料之日起即为受理;申请事项属于本行政机关职权范围，申请材料齐全、符合法定形式，或者申请人按照本行政机关的要求提交全部补正申请材料的，应当受理行政许可申请。
（二）审查：
行政受理服务中心受理后，即将申请材料送交医疗器械技术审评中心进行技术审评，技术审评包括产品检测和专家评审，技术审评不能超过60日。但经专家评审，对申请人提出整改意见的，申请人整改时间不计入许可时限。
（三）许可决定：
收到医疗器械技术审评中心完成技术审评的资料后，国家食品药品监督管理局在30日内作出予以注册或者不予注册的决定，不予注册的，应当书面说明理由。
（四）送达：
e time of the administration. (2) Review: After theadministrative acceptance service center accepts the application,the application materials will be sent to the Medical DeviceTechnical Review Center for technical review. The technical reviewincludes product testing and expert review, and the technicalreview shall not exceed 60 days. However, after the expertevaluation, for the applicant to put forward the rectificationopinion, the applicant's rectification time will not be included inthe licensing time limit. (III) License decision: After receivingthe data of the technical review center, the State Food and DrugAdministration makes a decision to register or not to registerwithin 30 days. If it fails to register, it shall explain thereasons in writing. (IV) Service:
