The FDA established a unique device identification system to identify medical devices through their distribution and use. It affects all medical device manufacturers and is being introduced in phases to allow time to change labeling, packaging, and internal documentation. In this video we’ll describe some of the key aspects of UDI, examine why it is necessary, and take a look at the benefits the program provides. We’ll also give you a good idea of what to expect as far as manufacture requirements go such as labeling and packaging.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多为了获得澳大利亚市场准入,医疗器械和体外诊断(IVD)器械制造商需要将他们的产品列入由药品管理局(TGA)监管的澳大利亚医疗用品登记表(ARTG)。
阅读更多