“械字号”大健康交叉产品的现状分析与监管对策研究

Research on the Supervision Status and Countermeasures of"Medical Devices Product Number"of Health Industry Cross-product

随着人们健康意识的增强和“颜值经济”的兴起,加之电商平台和直播卖货的推动作用,家庭保健和轻医美的理念逐渐走红,具有保健、美容、康复作用的产品受到市场青睐。与此同时,医疗器械虚假宣传和夸大功效的情况时有发生,宣称具有治疗功效的非医疗器械产品打“械字号”擦边球的现象依然存在。本文通过梳理“械字号”大健康类交叉产品现状,并综合热点事件、监管政策和整治行动,分析了健康类交叉产品存在的问题和治理情况,提出及时界定新兴大健康交叉产品的管理属性、强化对地方注册审批工作的检查和指导、发挥舆情监测在防治方面的作用等建议,以加强对“械字号”大健康交叉产品的有效治理。

With the enhancement of people’s health awareness and the rise of"beauty economy",as well as the promotion effect of e-commerce platforms and live commerce,the concept of family health care and micro aesthetic medicine is gradually becoming popular,and products with health care,beauty and rehabilitation functions are favored by the market.At the same time,false or exaggerated advertising of medical devices occur from time to time,and non-medical devices that claim to have therapeutic effect posed as medical devices still exists.Based on current situation of"medical devices product number"of health industry cross-product,this paper introduces the hot event,regulatory policy and special treatment,analyses the existing problems and governance situation,and puts forward some suggestions,such as defining the management attributes of emerging cross-product in time,strengthening inspection and guidance for local registration/approval,playing the role of public opinion monitoring in prevention and governance.