含无线技术医疗器械监管思考
Regulation Considerations of Medical Devices with Wireless Technology
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摘要: 无线技术在医疗器械中已得到广泛应用,在为医疗服务带来便利的同时,也面临着数据安全、辐射干扰等风险。从安全有效性评价的角度出发,对含无线技术医疗器械的技术特点、监管要点等方面进行初步探讨,以期为产业发展及监管提供参考。Abstract: Wireless technology has been widely used in medical devices and has brought convenience to medical care. However, wireless medical devices face risks such as data security and radio frequency interference. This study highlights safety and effectiveness evaluation of wireless medical devices, and discusses technical characteristics and regulation requirements, providing references for industry development and regulation.