You've done the hard work of classifying your product in the US - now it's time to get FDA clearance and start selling your device. But to sell a class 2 medical device in the US, you must submit a 510(k) to the US FDA. Knowing what to expect from this process can save you time, money, and some unnecessary headaches.
This short video provides an overview of the steps required to get your class II medical device cleared by the US FDA. From testing requirements to preparing your submission, this brief tutorial provides pertinent information on the 510(k) process and how to navigate it efficiently.
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
阅读更多自2022年5月26日始,欲在欧盟(EU)上市的新型体外诊断(IVD)医疗器械必须符合欧盟体外诊断医疗器械法规(2017/746 IVDR)。 同日起,带有有效CE标志的IVD可以继续按照指令98/79/EC(IVDD)进行销售,直至其许可证到期为止。 自2025年5月27日始,在欧盟销售的所
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