朝阳慈云寺北京医疗器械二类备案医疗器械三类经营许可证放心一站式代办周期短下证快

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：

自行政许可决定作出之日起10日内，SFDA行政受理服务中心将行政许可决定送达申请人。

1.承诺时限：自受理之日起，90日内作出行政许可决定。

2.实施机关：

实施机关：国家食品药品监督管理局

be accepted. (2) Review: After the administrative acceptanceservice center accepts the application, the application materialswill be sent to the Medical Device Technical Review Center fortechnical review. The technical review includes product testing andexpert review, and the technical review shall not exceed 60 days.However, after the expert evaluation, if the applicant is putforward the rectification opinion, the applicant's rectificationtime will not be included in the licensing time limit. (III)License decision: After receiving the data of the technical reviewcenter, the State Food and Drug Administration makes a decision toregister or not to register within 30 days. If it fails toregister, it shall explain the reasons in writing. (IV) Service:Within 10 days from the date of making the administrative licensedecision, the SFDA Administrative