医疗美容类激光产品技术审评的关注点

Concerns on Technical Evaluation of Medical Cosmetology Laser Equipment

激光医学是生物医学与激光技术的交叉领域,激光产品作用于人体的作用机理与其预期用途息息相关。技术审评可从医疗器械安全有效基本要求出发,综合衡量激光产品的所有风险以及非预期影响,要求其均应最小化并可接受,在正常使用中受益大于风险。该文从医疗器械注册技术审评的角度,分析医疗美容类激光产品在医疗器械技术审评过程中的主要关注点,为注册人/申请人和技术审评部门科学、合理地评价医疗美容类激光产品的安全性、有效性提供参考。

Laser medicine is an interdisciplinary field of biomedicine and laser technology and the mechanism of laser products acting on human body is closely related with the intended use.The technical evaluation may start from the essential principles of safety and performance of medical equipment and comprehensively measure all the risks and unexpected effects of laser products,which should be minimized and acceptable to ensure that the benefits outweigh the risks in normal use.This paper summarized the concerns during the technical evaluation of medical cosmetology laser equipment from the view of technical evaluation in order to provide references for the registers/applicants and the technical evaluation department to evaluate the safety and effectiveness of medical cosmetology laser equipment scientifically and reasonably.