家用光脱毛仪法规和标准现状分析

Analysis on the Current Situation of Regulations and Standards for Home Photoepilators

介绍了新型家用光脱毛仪的安全风险,并且分析了中国与美国、欧盟监管要求上的差异。在我国,家用强脉冲光脱毛仪也将按照医疗器械法规实施监管,因此,在没有具体法规情况下采用的安全标准已不适用于新的监管要求。采用适合家用光脱毛仪的新标准势在必行,以保证批准上市的产品安全有效。

This article introduces the safety risks of the novel light-based home-use hair removal device,and analyzes the differences in regulation among China,the United States and the European Union.In China,household intense pulsed light hair removal devices will also be supervised in accordance with medical device regulations.Therefore,the safety standards adopted in the absence of specific regulations are no longer applicable to the new regulatory requirements.It is imperative to adopt the new standards available to home photoepilators,so as to ensure the safety and effectiveness of the approved devices.