四、医疗器械三类经营许可证办理流程:
1、企业申请∶申请人向市食品药品监督管理局网站在线受理填写电请表,并上传办事指南要求的材料的附件,提交申请材料;
3、受理∶网上预审通过,提交纸质材料到市审批窗口,受理窗口发出受理通知书;
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。
1. What is a medical device? Beijing wants tounderstand the enterprises to see here Medical device: refers toinstruments, equipment, appliances, materials or other articlesused individually or in combination, including required software;their function on the surface of the body is not obtained bypharmacological, immunology or metabolic means, but may participateand play a certain auxiliary role. 2. How many categories aremedical devices divided into? There are three categories: Theoperation of the first type of medical devicesdoes