应用纳米材料类医疗器械产品现状探讨  

Discussion on the Current Status of Medical Devices with Nanomaterials

作　　者：张云娟 王晓晨 柴谦 王盛松 杜旭 ZHANG Yun-juan;WANG Xiao-chen;CHAI Qian;WANG Sheng-song;DU Xu(Shandong Center for Food and Drug Evaluation&Inspection,Shandong Jinan 250014)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《中国医疗器械信息》2024年第1期22-24,68,共4页China Medical Device Information

摘　　要：目的:掌握目前应用纳米材料类医疗器械产品的现状,探讨提升应用纳米材料类医疗器械产品质量的策略。方法:通过查询国内外文献及国家药品监督管理局网站,结合应用纳米材料类医疗器械产品企业的问卷调研情况,对应用纳米材料类医疗器械产品现状进行分析。结果:目前应用纳米材料类医疗器械产品上市产品少、大部分产品延续注册前需进一步完成许多研究工作等。结论:建议对已上市产品严格追溯控制上市产品质量,加强对未上市产品的安全有效性研究,加强对企业人员、审评人员和检查人员专业知识培训,促进应用纳米材料类医疗器械的高质量发展。Objective:This study seeks to gain insight into the current state of medical devices utilizing nanomaterials and to devise approaches for enhancing their product quality.Methods:National and international literature and the website of the National Medical Products Administration were reviewed,and a questionnaire survey of enterprises producing medical devices with nanomaterials was conducted to assess their risk and control.Results:Currently,there are few medical devices with nanomaterials on the market,and many products require further research before continuing registration.Conclusion:It is suggested to strictly trace the quality of listed products,strengthen safety and effectiveness studies of unlisted products,and strengthen professional knowledge training for enterprise personnel,reviewers and inspectors.To promote the high quality development of medical devices using nanomaterials.

关 键 词：应用纳米材料 医疗器械 质量管理 培训 

分 类 号：TH789[机械工程—仪器科学与技术]