中外常见美容设备分类界定现状的研究

Investigation on the Current Situation of Classification and Definition of Common Cosmetic Devices at Home and Abroad

该研究通过利用中国、美国和欧盟官方网站及数据库收集常见美容设备的分类界定信息,并进行了比较分析。目前,尽管医疗器械定义中未包含“美容”一词,但监管部门针对多数美容设备,尤其是高风险类专业设备,均根据设备的工作原理和预期用途,将其作为医疗器械实施监管;而对于家用美容设备,分类政策在不同地区、不同部门有不同的接受尺度。现阶段,监管部门是根据美容设备的风险来实施监管,而随着美容设备行业的快速发展,监管部门需要制定相应的法规和技术标准以满足新产品的发展需求。

Using the official websites and databases of China,the United States and the European Union,the classification and definition information of common cosmetic devices was collected and compared in this article.Although the term"cosmetic"is not included in the definition of medical devices,most cosmetic devices,especially highrisk professional devices,are supervised as medical devices by the regulatory authorities according to the working principle and intended use of the devices;For household cosmetic devices,the classification policy has different acceptance criteria in different regions and departments.At this stage,the regulatory authorities supervise the cosmetic devices according to the risk of each product.With the rapid development of the cosmetic devices industry,the regulatory authorities need to formulate corresponding regulations and technical standards to keep up with the development of new products.