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省药品监督管理局关于4家医疗器械生产企业暂停生产的通告

Notice from the Provincial Drug Administration on the Suspension of Production at Four Medical Device Manufacturers

No document number

Radar: Medical devices (rank 13 of 16)

Full text

近期，湖北省药品监督管理局在日常监管中发现以下4家企业未在《医疗器械生产许可证》登记地址从事医疗器械生产经营活动，且该地址已不具备生产条件。该行为严重违反了《医疗器械生产质量管理规范》的有关规定。依据《医疗器械生产监督管理办法》第六十四条第二款，湖北省药品监督管理局对该4家企业依法采取暂停生产的控制措施。特此通告。湖北省药品监督管理局 2024年6月7日（公开属性：主动公开）附件序号企业名称生产许可证编号 1 武汉珞格商用设备有限公司鄂食药监械生产许20200871号 2 武汉天玑医疗科技有限公司鄂食药监械生产许20221115号 3 菲仕医学设备（武汉）有限公司鄂食药监械生产许20200899号 4 国药泽睿（武汉）医疗科技有限公司临空中心鄂食药监械生产许20211051号附件:

Document

Status: Open (no dates found)
Issuer: 湖北省药品监督管理局
Level: Provincial
Region: 湖北省
Dated: 2024-06-07 (成文日期, from the document)
In force: not stated
Topic tree: Medical devices and equipment: 2 hops from 国务院令第739号
索引号: MB1529176/2024-23876

Original: http://mpa.hubei.gov.cn/zfxxgk/zc/qtzdgkwj/202406/t20240611…
Government sites can be slow from outside mainland China; the text here is our stored copy.

Cites (1)

国家市场监督管理总局令第53号
医疗器械生产监督管理办法 · 市场监管总局
by title

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湖北省药品监督管理局：《省药品监督管理局关于4家医疗器械生产企业暂停生产的通告》，2024-06-07。

Hubei Provincial Bureau of Drug Administration, 《省药品监督管理局关于4家医疗器械生产企业暂停生产的通告》 [Notice from the Provincial Drug Administration on the Suspension of Production at Four Medical Device Manufacturers], 7 June 2024.

Source: http://mpa.hubei.gov.cn/zfxxgk/zc/qtzdgkwj/2024… (archived capture)
Held copy: https://waitan-ludi.xyz/terminal/policies/17331/