中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2013年
1期
44-47
,共4页
欧阳黎明%赖玲波%冷德嵘%李宁%陆飞
歐暘黎明%賴玲波%冷德嶸%李寧%陸飛
구양려명%뢰령파%랭덕영%리저%륙비
售后监督%售后临床跟踪%医疗器械
售後鑑督%售後臨床跟蹤%醫療器械
수후감독%수후림상근종%의료기계
post-market surveil ance%post market clinical fol ow up%medical device
根据国际标准ISO14971及欧盟医疗器械法令93/42/EEC的有关要求,着重介绍了售后监督活动在医疗器械产品中的应用现状、实施重点和发展趋势,结合医疗器械生产企业对售后监督的实践经验,为医疗器械生产企业如何理解、实施售后监督提出了方法和建议.
根據國際標準ISO14971及歐盟醫療器械法令93/42/EEC的有關要求,著重介紹瞭售後鑑督活動在醫療器械產品中的應用現狀、實施重點和髮展趨勢,結閤醫療器械生產企業對售後鑑督的實踐經驗,為醫療器械生產企業如何理解、實施售後鑑督提齣瞭方法和建議.
근거국제표준ISO14971급구맹의료기계법령93/42/EEC적유관요구,착중개소료수후감독활동재의료기계산품중적응용현상、실시중점화발전추세,결합의료기계생산기업대수후감독적실천경험,위의료기계생산기업여하리해、실시수후감독제출료방법화건의.
Based on the practices of the post-market surveil ance activities by Medical Device Manufacturer and theoretical study of the latest international standard ISO14971 and European Medical Device Directives 93/42/EEC, this article analyses the post-market surveil ance activities in Medical Device Manufacturer by introducing the status quo of applications, implementation emphasis and further trends of development, methods and suggestions are therefore given to implant medical device manufacturer for post-market surveil ance.
