2
01
111100000000271742
北京市药品监督管理局
《医疗器械生产许可证》延续
111100000000271742200017202700004
1111000000002717422000172027000
0
b30f37fd-3fde-4992-b517-dd7da8c90c9a
1106667c-bf05-4dd4-a8e3-cb1950b78854
2
01
市药监局
110000000000
北京市药品监督管理局
工作日8:30-17:30(8:30-9:00、12:00-13:30、17:00-17:30为延时服务时间)、周六9:00-13:00(周六为延时服务时间,需预约办理)、法定节假日不对外服务。
北京市政务服务中心:北京市丰台区西三环南路1号(六里桥西南角)(1-3层综合窗口)
1.依据《医疗器械生产监督管理办法》第十七条 的规定医疗器械生产许可证有效期届满延续的,应当在有效期届满前90个工作日至30个工作日期间提出延续申请。逾期未提出延续申请的,不再受理其延续申请。
原发证部门应当结合企业遵守医疗器械管理法律法规、医疗器械生产质量管理规范情况和企业质量管理体系运行情况进行审查,必要时开展现场核查,在医疗器械生产许可证有效期届满前作出是否准予延续的决定。
经审查符合规定条件的,准予延续,延续的医疗器械生产许可证编号不变。不符合规定条件的,责令限期改正;整改后仍不符合规定条件的,不予延续,并书面说明理由。
延续许可的批准时间在原许可证有效期内的,延续起始日为原许可证到期日的次日;批准时间不在原许可证有效期内的,延续起始日为批准延续许可的日期。2.如企业同时涉及《医疗器械生产许可证》许可事项或登记事项变更,应先办理完成相关变更后再申请《医疗器械生产许可证》延续。
具体受理条件为:1.按照标准查验申请材料,相关材料可以通过联网核查的,无需申请人提供;2.申请事项属于市药监局职权范围,申请材料齐全、符合法定形式的,应当受理申请;3.申请资料存在可以当场更正的错误的,应当允许申请人当场更正;4.申请事项依法不属于市药监局职权范围的,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;5.申请资料不齐全或者不符合法定形式的,应当当场或者在5个工作日内一次告知申请人需要补正的全部内容,逾期不告知的,自收到申请资料之日起即为受理;6.受理或者不予受理医疗器械生产许可申请的,应当出具加盖市药监局专用章和注明日期的受理或者不予受理通知书。
{"IS_GUIDE":"1","ITEM_REALITY_USELEVEL":"","SERVICE_OBJCT":"","LITTLEPROGRAM_CODE_ID":"","EYE_DISABILITY_GRAD":"","IS_CONSTRUCTION":"0","CL_SERVICE_TYPE":"","APP_CODE_ID":"","ISMONVEINCENTER":"0","YESNO_CITY_UNICOM":"0^1","CROSS_AREA":"","WECHAT_CODE_ID":"","FINANCIAL":"","LITTLEPROGRAM_CODE_NAME":"","BUSINESS_APPROVAL_DEPT":"北京市药品监督管理局","CROSS_AREA_ALL":"","CROSS_PROVINCE":"","POWER_NAME":"第二类、第三类医疗器械生产许可","ITEM_ATTRIBUTE":"03^04^05^07^11","EAR_DISABILITY_GRAD":"","LIB_DISABILITY_GRAD":"","CROSS_AREA_ATEXT":"","SPEAK_DISABILITY_GRAD":"","AGE":"","REGISTER":"","BGSYSTEM_APPROVAL_OTHER":"市药监局审批系统","ONLINE_HANDLING_DEPTH_STANDARD":"05","WIT_DISABILITY_GRAD":"","APPROVAL_TYPE":"1","WECHAT_CODE_NAME":"","POWER_CODE":"B4602500","DISABILITY_TYPE":"","MIND_DISABILITY_GRAD":"","POWER_ATTRIBUTE":"1","ACCEPTSERVICE":"99","ONLY_ID":"d0150cd5-cf8b-4d5f-8d7b-24a1a6ba0738","YES_NO_OPEN":"1","BGSYSTEM_APPROVAL_NAME":"2","APP_CODE_NAME":"","YWBLX_ID":"30f739c4-8c6d-4618-81b4-dd0fb799fb94","HOLDER":"","VERSION":"20211231"}
[{"ID":4189838,"TASKGUID":"b30f37fd-3fde-4992-b517-dd7da8c90c9a","T_ID":"2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81","P_ID":"","NAME":"办理人员是否为法定代表人或负责人本人","NODE_LEVEL":1,"NODE_PATH":"/2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81","CHILD_COUNT":2,"ORDER_NUM":1,"SERIAL_NUMBER":"1","CONDITION_ATTR":"01","IS_RADIO":"1","IS_SUPPORT":"1","SUMMARY":"1 办理人员是否为法定代表人或负责人本人\n\t1.1 是\n\t1.2 否","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"1","newOrderNum":"001","itemGuideConditionRelatedList":[]},{"ID":4189839,"TASKGUID":"b30f37fd-3fde-4992-b517-dd7da8c90c9a","T_ID":"61b651eb-a154-49c5-81ff-d9b64e0abc0a","P_ID":"2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81","NAME":"是","NODE_LEVEL":2,"NODE_PATH":"/2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81/61b651eb-a154-49c5-81ff-d9b64e0abc0a","CHILD_COUNT":0,"ORDER_NUM":1,"SERIAL_NUMBER":"1.1","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"001.001","itemGuideConditionRelatedList":[]},{"ID":4189840,"TASKGUID":"b30f37fd-3fde-4992-b517-dd7da8c90c9a","T_ID":"c8a005a5-8fc6-45a3-a00f-234c1d54b791","P_ID":"2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81","NAME":"否","NODE_LEVEL":2,"NODE_PATH":"/2e0d7f3a-1c93-49a9-8e1f-e9065cf50f81/c8a005a5-8fc6-45a3-a00f-234c1d54b791","CHILD_COUNT":0,"ORDER_NUM":2,"SERIAL_NUMBER":"1.2","CONDITION_ATTR":"02","IS_RADIO":"","IS_SUPPORT":"","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20220810\",\"TREE_TYPE\":\"\",\"CONSULTATION_QA\":\"\"}","parOrder":"","proOrder":"","newOrderNum":"001.002","itemGuideConditionRelatedList":[{"ID":23760588,"TASKGUID":"b30f37fd-3fde-4992-b517-dd7da8c90c9a","T_ID":"c8a005a5-8fc6-45a3-a00f-234c1d54b791","G_ID":"1c937e31-b3a1-480a-aced-d66fc02788dd","M_CODE":"201228","MATERIAL_ID":"453951f9-7255-490c-a877-f168cca811d0","CD_TIME":"Oct 27, 2023 11:28:31 AM","CD_BATCH":"2023102700016","DISTRIBUTETAG":"all-data^non-investment^111100000000271742^110000000000^non-construction^111100000000271742","DATAJSONTEXT":"{\"VERSION\":\"20210903\"}"}]}]
2
2
http://yzt.beijing.gov.cn/am/oauth2/authorize?service=bjzwService&response_type=code&client_id=000027174_02&scope=cn+uid+idCardNumber+reserve3+extProperties+credenceClass&redirect_uri=http%3A%2F%2Fxzsp.yjj.beijing.gov.cn%2Fbfdaww%2FYZTAuth
政务服务> 办事指南
《医疗器械生产许可证》延续
北京市
切换简洁版
-
承诺件
办件类型
-
0次
到现场次数
-
20工作日
法定办结时限
-
13工作日
承诺办结时限
办件承诺办结时限说明:(承诺时限为办理流程中“审查与决定”环节的计时时限)
办件承诺办结时限说明:
(承诺时限为办理流程中“审查与决定”环节的计时时限)