4、现场核查∶自受理之日起,区县食品药品监督管理局 5个工作日内现场核查。核查通过后审核、审批;
5、网上公告∶在北京市食品药品监督管理局网站公告后,由市局食品药品监督管理行政审批服务中心发证。
看到这里相信不少朋友都会感到头大,办理医疗器械三类经营许可证需要提交的资料众多,门类细致,不是个内行人还真有点搞不定,因为很多医疗器械经营企业会委托专业医疗器械三类许可证代办公司代为办理,高校解决办证问题。
医疗器械安全关系人民生命安危,因此国家对从事医疗器械生产和经营的企业进行严格把关,并对相关生产经营行为进行规范。今天我们就来聊一聊,根据Zui新医疗器械监督管理办理相关条例规定,在北京地区办理医疗器械三类经营许可证都有哪些条件及流程。
How long does it take to approve the registration of the class III medical device license? (1) Acceptance: The applicant shall apply to the Administrative Acceptance Service Center, submit the application materials in accordance with the catalogue listed in Article 6 of the Instructions, and the staff of the Acceptance Center shall examine the application materials in accordance with the requirements of the Acceptance Standards for the Registration and Application Materials of Domestic Third Class and Overseas Medical Devices (National Drug Administration [2005] No.111). Where the application item does not need to obtain an administrative license according to law, The applicant shall be informed immediately of the non-acceptance of the application; Where the application items do not fall within the scope of the functions and powers of the administrative organ according to law, A decision shall be made immediately, And inform the applicant to apply to the relevant administrative organ;