摘要
根据《医疗器械监督管理条例》《医疗器械注册管理办法》及《中华人民共和国药典》(2015年版)等,基于现行有效的国家标准、行业标准的要求,结合产品上市前准入要求对医用激光光纤安全有效性研究进行探讨。
We research on safety and effectiveness of medical laser fiber according to Medical Device Supervision and Administration Regulations,Medical Device Registration Management Measures and People?s Republic of China Pharmacopoeia 2015 edition,based on the current valid national standards,industry standards and mandate of technical evaluation.
作者
张龚敏
曾姝颖
李风梅
赖锦坝
蔡丹丹
ZHANG Gong-min;ZENG Shu-ying;LI Feng-mei;LAI Jin-ba;CAI Dan-dan(Center for Certification and Evaluation,Guangdong Drug Administration,Guangdong Guangzhou 510080;Guangzhou Research Institute of Synthetic Materials,Guangdong 510000)
出处
《中国医疗器械信息》
2019年第1期9-10,166,共3页
China Medical Device Information
关键词
医用激光光纤
安全有效性
medical laser fiber
safety and effectiveness
