关于医疗器械技术审评补正意见现场咨询有关事宜的通告(2024年第31号)20241128
发布时间:2024-11-28
为提高医疗器械注册技术审评补正意见咨询的质量和效率,满足注册申请人的咨询需求,自2024年12月2日起提交医疗器械技术审评补正意见咨询申请的,可预约现场/视频咨询,现将有关事宜通告如下:
一、咨询范围及形式
1.咨询范围:目前仅开放由审评部、临床部负责审评的尚处于待企业补正资料状态的产品注册、延续注册、变更注册及临床试验审批事项的咨询,其他事项进行网上咨询。
2.咨询形式:咨询形式包含现场/视频咨询、网上咨询,由注册申请人根据需要自行选择。现场/视频咨询时长默认30分钟。
(1)现场/视频咨询:因审评人员所在工作地点不同,分别为器审中心(北京)、器械长三角分中心(上海)、器械大湾区分中心(深圳),预约咨询形式依咨询问题有所限制。当咨询申请仅勾选非临床问题或临床问题其中一项时,可预约现场咨询;当咨询申请同时勾选非临床问题和临床问题且只有当审评人员均在同一工作地时,可预约现场咨询,否则系统默认只能选择视频咨询方式。
(2)网上咨询:不受上述因素影响。
提醒注意:提交申请前请确认咨询问题并关注申请项目的审评人员所在地点,结合实际情况选择恰当的咨询形式。
器审中心审评人员公示:https://www.cmde.org.cn/zxjs/spgzrygs/index.html
器械长三角分中心审评人员公示:https://www.ydcmdei.org.cn/center-publicity-spry
器械大湾区分中心审评人员公示:https://www.mdei.org.cn/central/publicity.html
二、咨询时间和地点
咨询时间:器审中心每周四(法定节假日除外)上午9:00~11:30,下午13:30~16:00;器械长三角分中心、器械大湾区分中心咨询时间由两个分中心根据工作安排确定,请关注咨询确认单。
现场咨询地点:
器审中心:北京市经开区广德大街22号院一区1号楼 器审中心一层业务大厅。
器械长三角分中心:上海市浦东新区学林路36弄研创园6号楼一层。
器械大湾区分中心:广东省深圳市福田区槟榔道3号深港国际科技园(广田国际中心)G栋906室。
三、咨询次数
按照中心规定,每个符合申请现场/视频咨询要求的事项,申请现场/视频咨询的次数原则上不超过3次,网上咨询次数1次,系统将根据既往已完成咨询次数进行核减;其他事项有4次网上咨询的机会。
四、咨询申请途径
注册申请人需使用CA登录网页版医疗器械注册企业服务平台(https://erps.cmde.org.cn/)提出咨询申请,经审评人员确认安排的咨询申请,注册申请人可登录医疗器械注册企业服务平台查看具体安排,包括咨询日期、咨询地点、时段、咨询桌号、视频会议号及会议密码(如有)等。
五、咨询办理
现场咨询:请注册申请人务必关注咨询单上的咨询地点,携带纸质咨询确认单、身份证原件(每人)、提前到达指定位置等候。
已经预约成功的视频咨询:请注册申请人认真阅读视频咨询确认单后附的视频会议简易操作流程,在咨询前做好准备,确保咨询人员所处网络环境满足视频会议要求,画面稳定、声音清晰。参与视频咨询的人员请将个人名称统一命名为“受理号+公司名称简称+姓名”(如CQZ2000001甲乙丙公司张三),在预约日期的相应时段开始前10分钟进入会议号。会议号具备等候室功能,审评人员未邀请进入会议的,屏幕显示等待主持人邀请进入会议的提示,请耐心等待审评人员确认,如等候过程中显示会议结束,请再次加入会议等候。如超过预约时段应开始时间视频会议仍未开始的,可以联系中心工作人员解决,联系电话:010-86452929。
六、注意事项
1.已成功提交咨询申请的,请及时关注、查看预约系统确认信息,每周三务必登陆系统查看咨询预约情况,已预约成功的咨询原则上不可取消。
2.已预约成功的现场/视频咨询,因审评人员原因导致咨询不能按时完成的,将由审评人员与注册申请人另行约定咨询时间和形式。
3.请注册申请人严格遵守咨询时间,服从工作人员管理,确保咨询秩序,现场咨询最多可入场咨询3人。
4.创新、优先、临床试验审批等特殊渠道的沟通交流,注册申请人可通过医疗器械注册企业服务平台(https://erps.cmde.org.cn/)提交申请,成功提交申请后,系统无相关确认信息,请等待主审老师电话、邮件沟通具体会议时间及方式。
5.为确保现场咨询工作平稳过渡,2024年12月2日前已经预约成功的视频咨询,不做调整。
特此通告。
国家药品监督管理局
医疗器械技术审评中心
2024年11月28日
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