助听器安全评价分析与若干思考
Analysis and Some Thoughts on Safety Evaluation of Hearing Aids
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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。Abstract: 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.