可穿戴式设备管理现状分析与思考

Analysis and Thinking on the Current Situation of Wearable Devices Management

随着技术的发展和市场需求,可穿戴式设备的应用越来越广泛,我国目前对于可穿戴式设备的产业和技术发展十分重视,但尚未专门就可穿戴式设备的监管问题发布针对性的法律法规或指导意见。通过对可穿戴式设备的发展、应用、技术特点、产品情况和使用方式等进行梳理,本文提出了其监管中面临的相关问题。对比美国、欧盟目前对于可穿戴式设备的管理政策,可见其目前对于该类产品的监管也没有特殊政策,仍是采用了对于普通医疗器械的监管原则。结合目前我国可穿戴式设备监管已有的相关法规文件和存在的问题,基于产品技术特点和临床使用需求,提出了可穿戴式设备属性界定应依据的原则、相关标准制修订的建议和监管政策制定方面应考虑的技术问题等。本文主要着眼于可穿戴式设备监管政策和技术方面的问题,相关内容可供监管部门和技术人员作为参考。

Wearable devices are widely applied with the development of technology and market demand.At present,Chinese government attaches great importance to the development of wearable device industry and technology,but has not issued specific laws,regulations or guidance on the supervision of wearable devices.By combing the development,application,technical characteristics,conditions and usage of wearable devices,this paper put forward the relevant problems in the supervision of wearable devices.Compared the existing policies in United States and the European Union about wearable devices,it can be seen that there is no specific policy for the supervision of wearable devices currently,and the regulatory principles for ordinary medical devices are still adopted.Combined with the existing regulatory documents and existing supervisory problems of wearable devices in China,based on the product technical characteristics and clinical requirements,this paper puts forward the principles for defining the wearable device attributes,the suggestions for the revision of relevant standards and the technical issues to be considered in the formulation of regulatory policies.This paper focused on issues related to regulatory policy and technology of wearable devices.The relevant content can be used as a reference by regulatory department and technical personnel.