摘要
该文分析了国内外助听器产品的法规和监管情况,从标准、技术审评与监管各个层面上对助听器安全评价提出建议,希望对注册申报和监管有所帮助。
Based on analysis of the domestic and foreign laws and regulations for hearing aids, some suggestions of safety evaluation about standards, premarket technical review and regulation are presented in this article. It is hoped to be helpful for registration and regulation of hearing aids.
作者
牛帅
塔娜
王晓玲
NIU Shuai;TA Na;WANG Xiaoling(Center for Certification and Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020;Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100044)
出处
《中国医疗器械杂志》
2019年第2期129-131,共3页
Chinese Journal of Medical Instrumentation
关键词
助听器
安全评价
电气安全
电磁兼容性
hearing aids
safety evaluation
electric safety
electromagnetic compatibility
