Gao Zhong, Niu Shuai, Zhang Peiming
Shanghai Testing and Inspection Institute for Medical Devices, Shanghai, 201318.
Center for Certification and Evaluation, Shanghai Food and Drug Administration, Shanghai, 200020.
Zhongguo Yi Liao Qi Xie Za Zhi. 2019 Nov 30;43(6):439-441. doi: 10.3969/j.issn.1671-7104.2019.06.013.
In view of the background that the regulation of medical device supervision and management is about to cancel the registration and inspection, this paper analyses the risk of electromagnetic compatibility of medical devices, combs the current situation of electromagnetic compatibility testing, discusses the factors to be considered in the approval of third-party testing reports, and gives relevant solutions suitable for China's national conditions.
鉴于医疗器械监督管理即将取消注册检验的背景，本文分析了医疗器械电磁兼容性风险，梳理了电磁兼容性测试现状，探讨了第三方测试报告审批中需考虑的因素，并给出了适合我国国情的相关解决方案。
