摘要
当前,医疗美容类有源医疗器械在以注册为目的的型式检验阶段需要首先制定产品技术要求,产品技术要求的部分内容可参考相关行业标准或者国家标准。但为了体现医疗美容类有源医疗器械特点,切实保障产品使用过程中的有效性,需要在现有可参考标准的基础上增加专门的性能技术要求。通过对当前国家标准及行业标准的调研、分析,结合医疗美容类有源医疗器械的具体应用,对产品技术要求中体现产品特点的性能相关指标的制定提出技术建议,以期对制造商、型式检验和技术审评部门进一步完善和规范对医疗美容类有源医疗器械的安全有效性评价提供参考。同时,对后续针对医疗美容用途医疗器械的监管及标准制修订工作,进行分析和展望。
At present,in the registration and inspection stage of medical cosmetic active medical devices,it is necessary to first develop product technical requirements.Some of the content of product technical requirements can refer to relevant industry standards or national standards.However,in order to reflect the characteristics of medical cosmetic active medical devices and ensure the effectiveness of the product during use,it is necessary to add specialized performance technical requirements on the basis of existing reference standards.Through research and analysis of current national and industry standards,combined with the specific application of medical beauty active medical devices,technical suggestions are proposed for the development of performance related indicators that reflect product characteristics in product technical requirements,in order to further improve and standardize the safety and effectiveness evaluation of medical beauty active medical devices for manufacturers,type inspection and technical evaluation departments,and provide reference.At the same time,an analysis and outlook were conducted on the regulatory and standard formulation and revision work for medical cosmetic devices in the future.
作者
李佳戈
戎善奎
LI Jia-ge;RONG Shan-kui(National Institutes for Food and Drug Control,Beijing 102629)
出处
《中国医疗器械信息》
2024年第3期4-6,共3页
China Medical Device Information
关键词
医疗美容
有源医疗器械
技术要求
探讨
medical beauty
active medical devices
technical requirement
discuss
