一批医用冷敷贴被取消备案！

2022-09-08 16:45:28 www.gzxulin.com

近日，广州市市场监督管理局取消一批第一类医疗器械产品备案，其中包含21款医用冷敷贴、11款冷敷凝胶和1款医用冷敷眼罩。

通知称，《国家药监局关于发布第一类医疗器械产品目录的公告》（2021年第158号）在品名举例中删除了“医用冷敷贴、医用冷敷头带、医用冷敷眼罩、冷敷凝胶”。上述备案人没有按要求，于2022年4月1日前完成备案信息变更，或向原备案部门提出取消原备案、重新办理第一类医疗器械备案。

故按照《国家药监局关于第一类医疗器械备案有关事项的公告》（2022年第62号）中的《第一类医疗器械备案操作规范》，取消上述33个第一类医疗器械产品备案。取消备案后备案人不得再继续生产相应医疗器械。

具体名单如下：

广州旭林精细化工有限公司

标签: 医用冷敷贴取消备案

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