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Published on: October 20, 2021
[Regulation Considerations of Medical Devices with Wireless Technology]
Xiaoling Wang1, Shuai Niu1, Zhizhen Zhong1
1Certification and Evaluation Center of Shanghai Food and Drug Administration, Shanghai, 200003.
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.
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