医疗器械注册中认可社会第三方电磁兼容检测的可行性和对策研究

Study on Feasibility and Countermeasures of Social Third-party EMC Testing for Medical Device Registration

针对医疗器械监督管理条例即将取消注册检验的背景,该文分析了医疗器械电磁兼容风险,梳理了目前电磁兼容检测现状,探讨了认可社会第三方检测需要考虑的因素,并提出适合我国国情的相关建议。

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.