三类医疗器械许可证注册审批大致需要多久?
(一)受理:
申请人向行政受理服务中心提出申请,按照本《须知》第六条所列目录提交申请材料,受理中心工作人员按照《境内第三类、境外医疗器械注册申报资料受理标准》(国药监械[2005]111号)的要求对申请材料进行形式审查。申请事项依法不需要取得行政许可的,应当即时告知申请人不受理;申请事项依法不属于本行政机关职权范围的,应当即时作出不予受理的决定,并告知申请人向有关行政机关申请;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。
enter shall examine the application materials in accordance withthe requirements of the Acceptance Standards for the Registrationand Application Materials of Domestic Third Class and OverseasMedical Devices (National Drug Administration [2005] No.111). Wherethe application item does not need to obtain an administrativelicense according to law, The applicant shall be informedimmediately of the non-acceptance; Where the application items donot fall within the scope of the functions and powers of theadministrative organ according to law, The decision shall be madeimmediately, And inform the applicant to apply to the relevantadministrative organ; Where there are errors in the applicationmaterials that can be corrected on the spot, The applicant shall beallowed to make corrections on the