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北京市药品监督管理局关于印发《北京市医疗器械快速审评审批办法》的通知

京药监发〔2025〕114号

Radar: Medical devices (rank 13 of 16)

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text not held We hold only 187 characters of this document: its page linked to a file we could not fetch, or the host refused us. The title, issuer and date are held; measures and citations inside the text are not, so this document is missing from those counts. Original page.

京药监发〔2025〕114号各有关单位：为进一步提升我市医疗器械审评审批效率，加大释放创新开放市场活力，助力发展新质生产力，服务首都医疗器械产业高质量发展，北京市药品监督管理局结合工作实际及相关政策法规变化，组织修订了《北京市医疗器械快速审评审批办法》，经2025年第7次局长办公会议讨论通过，现予以印发，自发布之日起施行。北京市药品监督管理局 2025年8月1日

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Status: In force
Issuer: 北京市药品监督管理局
Level: Provincial
Region: 北京市
Dated: 2025-08-01 (成文日期, from the document)
In force: 2025-08-01
Topic: 市场监管、安全生产监管/食品药品监管

Original: https://www.beijing.gov.cn/zhengce/zhengcefagui/202510/t202…
Government sites can be slow from outside mainland China; the text here is our stored copy.

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北京市药品监督管理局关于印发《北京市第二类有源医疗器械变更注册技术审评规范》的通知
北京市药品监督管理局 · 2025-12-27

“依据北京市药品监督管理局（以下简称市药监局）发布的《北京市医疗器械快速审评审批办法》（京药监发〔2025〕114号）文件要求，有源医疗器械仅减少型号的变更事项，按照产品变更备案程序办理，可不参考本审评规范。”

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北京市药品监督管理局：《北京市药品监督管理局关于印发《北京市医疗器械快速审评审批办法》的通知》（京药监发〔2025〕114号），2025-08-01。

Beijing Municipal Bureau of Drug Administration, 《北京市药品监督管理局关于印发《北京市医疗器械快速审评审批办法》的通知》, 京药监发〔2025〕114号, 1 August 2025.

Source: https://www.beijing.gov.cn/zhengce/zhengcefagui…
Held copy: https://waitan-ludi.xyz/terminal/policies/11821/