The European Union comprises 28 countries that require CE Marking. Three additional countries (Norway, Iceland, Liechtenstein), although not officially part of the European Union, are signatories to the European Economic Area (EEA). Switzerland is not an EU member nor a signatory to the EEA, but they have transposed the Medical Devices Directives into their national law and these countries require CE Marking.
We can assist you in obtaining CE Marking so you can sell your medical device in any of these European countries.
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)。
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