首页|山东省医用防护服产品审评发补常见问题分析及展望

山东省医用防护服产品审评发补常见问题分析及展望

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医用防护服是疫情防控工作中的重要医疗装备,符合要求的医用防护服有力降低了交叉的感染,保证了医护人员的人身安全.2020年以来,医用防护服注册量随着公共卫生安全需求而激增,文章汇总自2020年1月~2023年10月山东省食品药品审评查验中心的203件的医用防护服注册申请件,梳理了审评发补中的常见问题,希望能对产品的注册申报提供一定的帮助,提高注册及审评效率.
Analysis of Common Problems and Future Development Direction of Medical Protective Clothing Products in Shandong Province
Medical protective clothing is an important medical equipment in the prevention and control of epidemic.Medical protective clothing that meets the requirements can effectively reduce cross-infection and ensure the personal safety of medical workers.Since 2020,the number of medical protective clothing registrations has surged with the demand for public health and safety.This paper summarizes 203 medical protective clothing registration applications from Shandong Food and Drug Evaluation and Inspection Center from January 2020 to October 2023,and sorts out common problems in the review and issuance,hoping to provide certain help for product registration and application.Improve registration and review efficiency.

medical protective clothingregistrationreview

王亚琳、王晓晨、闫芳、杜旭、张梅、张璐

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山东省食品药品审评查验中心(山东 济南 250014)

医用防护服 注册 审评

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(5)
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